Received: 4 January 2017 | Revised: 1 May 2017 | Accepted: 10 June 2017

DOI: 10.1111/cid.12520

ORIGINAL ARTICLE

Evaluation of complication rates and vertical bone gain after

guided bone regeneration with non-resorbable membranes
versus titanium meshes and resorbable membranes.
A randomized clinical trial

Alessandro Cucchi, DDS, MSClin, PhD | Elisabetta Vignudelli, DDS, MSc, PhD |
Aldo Napolitano, DDS, MSc | Claudio Marchetti, MD, MSClin |
Giuseppe Corinaldesi, MD, DDS, MSClin

Unit of Oral and Maxillofacial Surgery,

Department of Biomedical and Neuromotor
Abstract
Science (DIBINEM), Alma Mater Studiorum -
Background: The partial edentulous posterior mandible is often a challenge area that requires a
University of Bologna, Bologna, Italy
bone reconstructive surgery for implants placement.
Correspondence
Purpose: This RCT was aimed to evaluate complications rate and vertical bone gain after Guided
Alessandro Cucchi, Via della resistenza,
10 – 46036 – Revere (MN), Italy. Bone Regeneration (GBR) with dense non-resorbable d-PTFE titanium-reinforced membranes
Email: [email protected] (Group A) versus titanium meshes covered by cross-linked collagen membranes (Group B).

Material and Methods: 40 partially edentulous patients with atrophic posterior mandible, were
randomly divided into two study group: 20 patients were treated with one stage GBR by means of
non-resorbable d-PTFE titanium-reinforced membranes (Group A); and 20 patients, by means of
titanium mesh covered by cross-linked collagen membranes (Group B). All complications were
recorded, distinguishing between “surgical” and “healing” and between “minor” or “major.”. Primary
implants stability and vertical bone gain were also evaluated.

Results: In the group A, surgical and healing complication rates were 5.0% and 15.0%, respec-
tively. In the group B, surgical and healing complication rates were 15.8% and 21.1%, respectively.
No significant differences between two study group were observed regarding complications rate
implant stability and vertical bone gain.

Conclusions: Both GBR approaches for the restoration of atrophic posterior mandible achieved
similar results regarding complications, vertical bone gain and implant stability.

KEYWORDS
alveolar ridge reconstruction, atrophy, bone augmentation, bone defects, bone regeneration, eden-
tulous mandible, guided bone regeneration

The copyright line in this article was changed on 3 October 2017 after online
publication.
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V
C 2017 The Authors. Clinical Implant Dentistry and Related Research Published by Wiley Periodicals, Inc.

Clin Implant Dent Relat Res. 2017;19:821–832. wileyonlinelibrary.com/journal/cid | 821

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822 | CUCCHI ET AL.

1 | INTRODUCTION that must be regenerated after placement of implants in a three-

dimensional “ideal” position; (3) capacity to understand and accept the
Alveolar atrophy is a pathological condition characterized by moder- conditions of the study; and 4 continuing participation in the study for
ate or severe resorption of alveolar bone due to tooth loss.1,2 at least 1 year of follow up.
The loss of teeth determines the loss of the functional stimulus for The exclusion criteria were as follows: (1) residual bone
the alveolar bone. Consequently, the bone undergoes constant and height < 5 mm; (2) insufficient oral hygiene; (3) a smoking habit of > 10
predictable resorption, which differs depending on location: in the cigarettes/day; (4) abuse of alcohol or drugs; (5) pregnancy; (6) acute
mandible, it is primarily horizontal; in interforaminal regions, it is local or systemic infection; (7) uncontrolled diabetes or other metabolic
centripetal; however, it is vertical and centrifugal in retroforaminal disease; (8) severe hepatic or renal dysfunction; (9) HIV, HBV, or HCV;
areas.3,4 Alveolar bone resorption and the presence of the inferior (10) chemotherapy or radiotherapy within the last 5 years; (11) immu-
alveolar nerve (IAN) make the posterior regions of the mandible nosuppression therapy; (12) autoimmune disorders; or (13) bisphospho-
5
the most challenging to treat using osseointegrated implants. nate therapy.
Bone-augmentation techniques proposed to increase bone volume We planned to treat 40 patients; they were randomized into
in the posterior regions of the mandible include bone grafts (inlay two study groups, depending on a previous computer-generated ran-
and onlay), osseodistraction, transposition of the IAN, titanium domization sequence. Group A included 20 patients treated by means
mesh, and guided bone regeneration (GBR).6 of a dense PTFE (d-PTFE) titanium-reinforced membrane, and Group B
In the last 10 years, short- and long-term studies have demon- included 20 patients treated by means of a titanium mesh (Ti mesh)
strated that GBR is a successful and reliable technique for vertical and and cross-linked collagen membrane.
horizontal ridge augmentation.5,7–11 GBR can be achieved with two Patients who met the inclusion criteria were informed about the
different approaches: application of either a polytetrafluoroethylene objectives and conditions of the study. Each patient received written
(PTFE) titanium-reinforced membrane (ie, a non-resorbable membrane) information and provided written informed consent before participation
or a collagen membrane (ie, a resorbable membrane).7,12–15 To achieve in any study-related procedure. After enrollment, each patient received a
vertical bone augmentation, a resorbable membrane must be supported unique identification number, according to which all data were recorded.
by a space-making device, such as a titanium mesh (Ti mesh) or a tita- Patient was blinded and did not know the assigned study group.
nium osteosynthesis plate.14,15
However, the use of a barrier device is a technique-sensitive pro-
2.2 | Clinical procedures
cedure that is not free of complications. The main cause of GBR failure
is related to early or late exposure of a barrier device, leading to con- Following selection, all patient data (ie, personal, medical, and diagnos-
tamination and infection of the biomaterial, irreversibly compromising tic data) were recorded on a specific data collection form (CRF), which
bone regeneration. 16–19 was completed on each day of monitoring. Prior to surgery, all patients
In this randomized clinical trial, we sought to evaluate complication were evaluated and treated for periodontal and dental health and
rates and vertical bone gain (VBG) after GBR with dense PTFE received oral hygiene instructions. All patients received prophylactic
titanium-reinforced membranes versus with titanium mesh covered antibiotic therapy with 2 g of amoxicillin and clavulanic acid (or 600 mg
with cross-linked collagen membranes. of clindamycin in cases of penicillin allergies) and anti-inflammatory
therapy with 100 mg of nimesulide 1 h before treatment (or 600 mg of

2 | MATERIAL AND METHODS Ibuprofen in cases of nimesulide allergies).

Surgical and prosthetic protocol

This study was designed as a pilot, parallel-group, double-blind,
On the day of the implant and reconstructive surgery (T0), local anes-
randomized, comparative clinical trial. The study was conducted in
thesia was administered: articaine 4% with epinephrine 1:100.000. A
accordance with the principles of the Declaration of Helsinki. The
mid-crestal horizontal incision within the keratinized tissue of the
study was approved by the Ethical Committee of the Sant’Orsola-
edentulous ridge was extended distally to the external oblique ridge of
Malpighi Hospital (Prot. CMF 01/2013; number 30/2013/O/Disp).
the mandibular ramus. To preserve the lingual nerve when approaching
the third molar area, the incision was inclined at 458 in the buccal
2.1 | Study design and patient selection direction, using the external oblique ridge as a reference line. The mid-
The study included 40 patients with partial edentulism, associated with crestal horizontal incision was extended mesially on the gingival sulcus
alveolar atrophy in the posterior regions of the mandible, who were of the two adjacent teeth, forming two vertical incisions on the buccal
referred to the Unit of Oral and Maxillofacial Surgery, Alma Mater and lingual sides. Taking care to avoid flap laceration or perforation, we
Studiorum, University of Bologna, Italy. The inclusion criteria were as elevated a full-thickness surgical flap buccally and lingually; the mental
follows: (1) edentulism in posterior regions of the mandible with verti- nerve was gently isolated, and the mental foramen was exposed.
cal and horizontal bone resorption of the alveolar ridge requiring three- Because careful management of the soft tissue was important for
dimensional bone regeneration and implant-supported rehabilitation; obtaining and maintaining primary closure of the surgical flap above
(2) a vertical peri-implant bone defect of  2 mm in the alveolar ridge the area of bone regeneration, particular care was taken to passivate
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CUCCHI ET AL. | 823

and release the buccal and lingual flaps in the order that each would
advance coronally, as suggested by Ronda et al. in 2011 and 2015;
Todisco et al in 2010 and Maiorana et al. in 2001and 2005.12,20–23
One or more tapered implants with double-variable thread designs
and a double-acid-etched (DAE) surface (BT SAFE; Biotec srl, Vicenza,
Italy) were placed in the three-dimensional “ideal” position to stabilize
the barrier device and to maintain a three-dimensional space under it.
Implant sites were prepared according to the manufacturer’s protocol,
using twisted drills and/or piezoelectric inserts to complete implant
FIGURE 1 Preoperative clinical view
sites, depending on proximity to the IAN. Subsequently, tapered
implants were inserted in the corresponding sites until achieving the at 600 mg/day for 6 days (in penicillin-allergic patients). Anti-
optimal position (ie, the implant platform was 3 mm apical to the gin- inflammatory therapy with NSAIDs was also recommended: nimesulide
gival margin of the two adjacent teeth, independent of alveolar ridge (Aulin; Helsinn Birex Pharmaceuticals Ltd., Dublin, Ireland) at 200 mg/
levels). Thus, the most coronal portion of the implants was left to pro- day for 3 days and 100 mg/day for 3 more days or ibuprofen (Brufen;
trude from the alveolar ridge, showing the amount of planned vertical Gekofar, Milan, Italy) at 1800 mg/day for 3 days and 1200 mg/day for
bone regeneration. Because the implants protruded coronally over the 3 more days (in nimesulide-allergic patients).
alveolar ridge level, the vertical bone peri-implant defect could be For the first 15 days, patients were instructed to consume a fluid
measured accurately due to vertical and horizontal bone resorption. diet, whereas patients were instructed to consume a soft diet and to
After implant placement, the cortical bone of the mandible was exercise good oral hygiene for the next 15 days. We also recom-
perforated repeatedly to reach the bone marrow to promote the migra- mended three 2-min treatments of chlorhexidine 0.2% (Curasept ADS;
tion of osteogenic cells and osteoprogenitor stem cells and the forma- Curaden Healthcare srl, Varese, Italy) each day. Sutures were removed
tion of coagulum under the barrier device. 15 days after surgery.
Additionally, 0.5–1.0 g of autogenous bone was harvested from On the day of the reopening surgery (T1), after 9 months of sub-
the external oblique ridge of the mandibular ramus using a bone merged healing, a mid-crestal horizontal incision within the keratinized
scraper (Safescraper, Meta, RE, Italy); grafting material for bone regen- tissue was performed without vertical incisions to remove the barrier
eration was prepared by mixing 50% autogenous bone and 50% bone devices and the mini-screws, to measure the vertical peri-implant bone
allograft (EnCore, Osteogenics Biomedical, Lubbock, Texas). gain around each implant, and to expose the submerged implants using
At this point, the randomization envelope was opened, and the healing screws. Moreover, a connective tissue graft was performed on
assigned treatment was revealed to the surgeon: a d-PTFE titanium- the buccal side to increase the thickness of the peri-implant soft tissues.
reinforced membrane (Cytoplast Ti-250XL; Osteogenics Biomedical) On the day of functional loading (T2), 2–3 months after reopen-
was used in Group A, whereas a Ti mesh (Trinon Titanium; Karlsruhe, ing surgery, the implant-supported fixed metal-ceramic restorations
Germany) and cross-linked collagen membrane (Osseoguard, Zimmer were delivered to the patients. All definitive restorations were placed

Biomet, Warsaw, Indiana) were used in Group B. in occlusion, where the occlusal surface was thoroughly modeled so

The d-PTFE membrane or Ti mesh was modeled and adapted to that it was in contact with reduced areas during laterality and protru-

maintain a three-dimensional space for bone regeneration. First, it was sion excursions, to reduce the dislocating vectorial components; more

fixed on the lingual side using two or more titanium mini-screws. Then, contacts were maintained in maximum intercuspidation.

the grafting material, consisting of a 50:50 mixture of bone allograft Figures 1–10 showed a clinical case of Group A. Instead Figures
11–20 showed a clinical case of Group B.
and autogenous bone, was carefully positioned around the implants to
restore, vertically and horizontally, the peri-implant bone defect.
Finally, the d-PTFE membrane or Ti mesh was fixed definitively on the
buccal side using two or more titanium mini-screws. The collagen mem-
brane was applied over the Ti mesh, according to the principles of
guided bone regeneration (GBR).
After evidence that the surgical flaps could advance coronally
without tension to cover the augmented area, a double suture (Cyto-
plast PTFE suture; Osteogenics Biomedical) was used to ensure pri-
mary closure of the surgical wound. Horizontal mattress sutures were
used for flap overlapping, whereas multiple interrupted sutures were
used for hermetic closure of the flaps.12,13,20,24,25
Antibiotic therapy was prescribed to reduce the risk of infections:
amoxicillin plus clavulanic acid (Augmentin; GlaxoSmithKline, Verona,
Italy) at 3 g/day for 7 days or clindamycin (Dalacin; Pfizer srl, Italy) FIGURE 2 Preoperative peri-apical x-rays
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824 | CUCCHI ET AL.

FIGURE 5 Clinical healing at 9 months

The latter complications were divided into four classes, according to

FIGURE 3 Cortical perforations and implants insertion the presence and extent of exposure, as well as the presence of a puru-
lent exudate.
2.3 | Data collection
During surgery and postoperative visits, all clinical and healing data  Class I: membrane exposure  3 mm, no purulent exudate.
were recorded on a specific data collection form (CRF), which was  Class II: membrane exposure  3 mm, no purulent exudate.
completed on each day of intervention or monitoring. All data were
 Class III: membrane exposure, with purulent exudate.
collected by a blinded examiner.
 Class IV: abscess, without membrane exposure.
Implant stability
Healing complications were also divided into major or minor, depend-
Implant stability was evaluated with two different methods: insertion
ing on the influence on newly formed bone, according to Merli et al
torque (IT, expressed in Ncm) and resonance frequency analysis (RFA,
2007.14
expressed in ISQ). IT was measured with a manual dynamometric
torque wrench, able to measure torques up to 100 Ncm. RFA was used Peri-implant bone defects and vertical bone gain
€ teborg,
to measure the implant stability quotient (ISQ) (Osstell AB, Go A peri-implant bone defect was defined as the vertical distance
Sweden). These variables were evaluated for each implant in Groups A between the top of the implant shoulder and the first visible bone-
and B at T0 and T1. implant contact. It was recorded during T0 to assess the initial
peri-implant bone defect (IBD) and during T1 to assess the “final” peri-
Surgical and healing complications
implant bone defect (FBD). These variables were assessed at four sites
Complications were evaluated for Groups A and B from T0 to T2. They
(mesial, distal, buccal, and lingual) around each implant using a Univer-
were divided into surgical complications and healing complications, as
19 sity of North Carolina (UNC)-15 periodontal probe with a 1-mm grad-
suggested by Fontana et al. 2011. The former complications were
uated scale, rounding values to the nearest 0.5 mm. Implants were
classified as:
used as reference point for direct measurements of bone augmentation
 Class A, including flap damage (soft tissue perforation or laceration), before and after surgery.

 Class B, including neurological damage (paresthesia or disesthesia), and The vertical bone gain (VBG) was calculated as the difference
between the FBD and IBD at the four sites (mesial, distal, buccal, and
 Class C, including vascular damage (hemorrhage).
lingual) for each implant. It was expressed in millimeters (mm).

F I G U R E 4 D-PTFE membrane fixation and bone grafting with

autogenous bone and bone allograft FIGURE 6 D-PTFE membrane after 9 months
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CUCCHI ET AL. | 825

FIGURE 7 D-PTFE membrane removal at the reopening surgery

2.4 | Data management and statistical analysis

Data management
FIGURE 9 Peri-apical x-rays after healing screws placement
We used a data collection form and data management system using
Excel (Microsoft Excel 2011; Windows, ver. 14.0.0). Data were entered investigated using t-tests for unpaired data. Statistical significance was
by a blinded operator. Before entry, data were evaluated for accuracy set at a 5 0.05. The statistician was blinded and external to working
and completeness; logical consistency was verified, and the ranges of group.
quantitative data were computed. Data were analyzed using the SPSS
software (ver. 8.11.5; SPSS, Inc, Chicago, Illinois).
3 | RESULTS
Statistical analysis
The power-analysis showed that with a minimum of 17 patients per
3.1 | Intent-to-treat population
group (total of 34 patients), it will be possible to detect a 35% differ-
ence in complications and a difference of 1 mm in VBG between the In total, 40 patients (13 males, 27 females) with a mean age of 52 years
two groups with a standard deviation r 51 and a significance level of were treated according to the protocol described previously. All
a 5 0.05 with a power of 80%. To protect from possible drop-outs, the patients underwent bone augmentation surgery and received 108
sample size was increased by to 20 patients per group (total of 40 implants to restore posterior regions of the mandible. All implants were
patients). placed simultaneously with guided bone regeneration (GBR) proce-
The results obtained in the two study groups (Groups A and B) dures: implant diameters were 3.7, 4.1, and 4.8 mm and implant lengths
were subjected to statistical description and analyses using specific were 8, 10, and 12 mm. All implants were inserted in Type I or II bone,
tests to determine statistically significant differences between them. according to Lekholm and Zarb’s classification.26
Both the intent-to-treat and per-protocol populations were analyzed. Of the 40 patients, 18 (45.0%) were classified as ASA I and 22
The patient was regarded as the statistical unit of analysis for all analy- (50%) as ASA II. No patient with ASA III or IV status was treated. More-
ses, except that of implant stability, which was carried out considering over, 29 (72.5%) were non-smokers, and 11 (27.5%) smoked fewer
the implant as the statistical unit. Statistical differences in complication than 10 cigarettes per day.
rates were investigated using Fisher’s exact test. Differences in implant Of the 40 patients, 23 (57.5%) had no periodontal disease, 12
stability, peri-implant bone defects, and VBG at T0 and T1 were (30.0%) had chronic periodontitis, and 5 (12.5%) had aggressive

F I G U R E 8 Three-dimensional bone regeneration around implants

occlusal view FIGURE 10 Peri-apical x-rays after definitive restoration
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826 | CUCCHI ET AL.

FIGURE 11 Preoperative clinical view FIGURE 13 Cortical perforations and implants insertion

periodontitis. All periodontal patients were treated with periodontal 3.3 | Primary implant stability
therapy before augmentation and implant surgery.
All implants (n 5 108, 100%) were placed according to the initial
implant-prosthetic treatment planning. Of the 108 implants, 106
3.2 | Per-protocol population (97.2%) showed optimal primary stability, with insertion torque val-
ues > 35 Ncm and ISQ values > 60. The mean insertion torque was
All 40 patients underwent implant and bone augmentation surgery (at
80 6 10 Ncm, whereas the mean RFA value was 86.5 6 5.0 ISQ. Bone
T0).
density was Type I and II at all sites.
During the healing period (T0-T1), one patient with three implants
In Group A, at T0, the mean IT was 80.0 6 10.0 Ncm, and the
dropped out immediately after the GBR procedure due to a car crash
mean RFA value was 87.0 6 5.0 ISQ. In Group B, at T0, the mean IT
involving maxilla-facial trauma. After the reopening surgery (T1-T2), one
was 79.0 6 10.0 Ncm, and the mean RFA value was 84.5 6 6.0 ISQ.
patient with three implants dropped out and did not undergo implant
There was no statistically significant difference between Groups A and
restoration with a definitive prosthesis for logistical and economic rea-
B regarding primary implant stability (P > .05).
sons. Additionally, three patients with seven implants did not undergo
At reopening surgery (T1), all implants (n 5 99, 100%) showed suc-
reopening surgery because major complications occurred, and the
cessful osseointegration after the submerged healing period. Reverse
removal of barrier devices and implants was required before T1. Conse-
torque at 25 Ncm was used to assess adequate osseointegration.
quently, 40 patients with 108 implants (20 in Group A and 20 in Group
Mean RFA values at reopening surgery were 71.0 6 8.0 ISQ and
B) were considered in the statistical analyses of variables recorded at T0.
66.5 6 10.0 ISQ in Groups A and B, respectively.
In total, 39 patients with 106 implants (20 in Group A and 19 in
Group B) were considered for the analysis of those variables recorded
between T0 and T1, and 36 patients with 99 implants (19 in Group A
3.4 | Surgical complications
and 17 in Group B) were considered for the variables recorded at T1.
Finally, 35 patients with 96 implants (18 in Group A and 17 in Group After the implant and bone augmentation surgeries (T0), four surgical

B) completed the entire study protocol with definitive restoration with complications occurred in four different patients. All these complica-

implants (T2). tions belonged to Class B: that is, neurological complications. No flap

FIGURE 14 Ti-mesh fixation and bone grafting with autogenous

FIGURE 12 Preoperative peri-apical x-rays bone and bone allograft
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CUCCHI ET AL. | 827

FIGURE 15 Application of collagen membrane over the Ti-mesh FIGURE 17 Ti-Mesh removal at the re-opening surgery

or vascular damage was recorded during T0. Moreover, no complica- rates of major and minor healing complication were 15.8% and 5.3%,

tion occurred in either group during T1. respectively. Table 2 provides a description of the healing complica-

In Group A, one case of temporary paresthesia of the mental nerve tions in Group B.

was observed, yielding a surgical complications rate of 5% (1/20). In No statistically significant difference was observed between

Group B, the surgical complications rate was 15.8% (3/19), because Groups A and B regarding the overall healing complication rates

three cases of temporary paresthesia of the mental nerve occurred. All (P 5 .69) or the major or minor healing complication rate (P 5 .99).

neurological injuries showed spontaneous recovery during the first

month after surgery. 3.6 | Peri-implant bone defect and vertical bone gain
The difference in the surgical complication rates between Groups
Mean values of peri-implant bone defects (IBD and FDB) and vertical
A and B was not statistically significant (P 5 .34).
bone gain (VBG) in the two groups are presented in Tables 3 and 4. In
Group A, IBD and FBD were 3.8 6 0.7 (range, 2.7–4.9) mm and 20.5 6
3.5 | Healing complications
0.6 (range, 21.2–0.4) mm, respectively. Consequently, in Group A, the
In total, 7 complications occurred in 39 patients during the healing VBG was 4.2 6 1.0 (range, 2.7–5.8) mm. Table 3 reports the values of
period (T0-T1). In Group A, three healing complications were observed, IBD, FDB, and VBG in Group A according to implant site. In Group A,
yielding an overall complication rate of 15.0% (n 5 3/20). Of these, two 63.0% (n 5 34) of the implants showed supra-implant bone overgrowth
complications (Classes III and IV) affected the amount of newly formed during T1. In these cases, an osteotomy was necessary to place healing
bone or the success of the bone augmentation surgery and were, screws. Only 25.9% (n 5 14) showed partial bone regeneration with
therefore, classified as major complications. One complication (Class II) the presence of a residual bone defect, which was always observed at
did not affect the amount of newly formed bone and was, therefore, buccal sites.
classified as a minor complication. In Group A, the rates of major and In Group B, the mean values of IBD (T0) and FBD (T1) were 4.0 6
minor healing complications were 10.0% and 5%, respectively. Table 1 0.8 (range, 2.9–5.4) mm and 20.2 6 0.7 (range, 21.0–1.3) mm, respec-
provides a description of the healing complications in Group A. tively. Consequently, in Group B, VBG was 4.1 6 1.0 (range, 2.6–6.3)
In Group B, four cases of healing complications were observed, mm. Table 4 presents the values of IBD, FDB, and VBG in Group B
yielding an overall complication rate of 21.1% (n 5 4/19). Of these, according to implant site. In Group B, 61.4% (n 5 27) of the implants
three (Class III and IV) were classified as major complications, whereas showed supra-implant bone overgrowth. Osteotomies were performed
one (Class II) was classified as a minor complication. In Group B, the in these individuals to place healing screws. Only 22.7% (n 5 10)

FIGURE 16 Clinical healing 9 months after surgery FIGURE 18 Three-dimensional bone regeneration around implants
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828 | CUCCHI ET AL.

FIGURE 19 Peri-apical x-rays after healing screws placement FIGURE 20 Peri-apical x-rays after definitive restoration

showed partial bone regeneration with the presence of a residual bone was used to achieve an adequate implant-prosthetic restoration.
defect at the buccal site. No statistically significant difference was Because this procedure is still considered to be highly technique-
observed between the groups in IBD, FBD, or VBG parameters sensitive and not free of complications that can affect the amount of
(P 5 .29, .20, and .58, respectively). newly formed bone and the success rate of the treatment, Fontana et al.
in 201119 suggested a classification of surgical and healing complications
and recommended that these be managed differently according to class.
4 | DISCUSSION To date, there have been many reports regarding complication
rates, vertical bone gain (VBG), and success rates after bone augmenta-
Many studies have demonstrated high success rates with dental
tion with PTFE membranes and Ti mesh.40,41 However, there have not
implants in terms of both function and esthetics.27–31 However, eden-
been randomized clinical studies comparing the clinical outcomes of
tulous areas are often characterized by alveolar bone atrophy due to
these two approaches.
the continued bone resorption that occurs after tooth loss.1,2,4
If a membrane or mesh remains submerged completely for at least
Although many studies have confirmed the reliability of short and
6–9 months of uneventful healing, it is possible to achieve complete
ultrashort implants in atrophic mandibles and maxillae,32,33 a three-
bone formation under the barrier device. However, if the membrane or
dimensional reconstruction of alveolar bone is often required to pro- mesh suffers early or late exposure, the amount of newly formed bone
vide an esthetic and functional restoration.34,35 It was reported that under the barrier could be affected negatively. Consequences of barrier
the mean vertical dimensions of a partially edentulous posterior mandi- exposure range from incomplete bone growth to failure of the entire
ble from the IAN to the edge of the bone crest were 8.7 6 5.6 mm and regenerative surgery.19
9.2 6 3.8 mm for the first and second molar areas, respectively.36. The The main cause of GBR failure is related to early or late exposure
horizontal dimensions were 6.6 6 3.0 mm and 6.9 6 3.2 for the first of the barrier device, leading to contamination and infection of the
and second molar areas, respectively.37 Because the presence of the biomaterials, irreversibly compromising bone regeneration.16–18,42–44
inferior alveolar nerve requires a “safety zone” of at least 1–2 mm38 Other complications, such as the onset of an abscess with purulent
and the resorption pattern in the retroforaminal area is vertical and exudate, can also lead to a complete failure of GBR even without expo-
centrifugal,3,4 most long-term edentulous patients do not have sure of the membrane.19
36,37,39
adequate bone volumes to place standard or short implants. In this study, healing complications in Group A were limited to one
Consequently, the posterior mandible is a challenging area that typi- case of early membrane exposure with infection, one abscess without
cally requires bone augmentation during or before implant surgery.35 exposure, and one case of late membrane exposure without infection.
In this study, guided bone regeneration (GBR) using d-PTFE Ti- The first two were considered major complications because they
reinforced membranes or Ti mesh covered with collagen membranes resulted in the failure of the entire regenerative and implant surgery: all

TA BL E 1 Complication rate and type in group A

Timing N. patients N. complications Complications features Complication class Complications type

0–1 month 20 1 Abscess without exposition Class IV Major

1–3 months 20 1 Early membrane exposure with infection Class III Major

3–6 months 20 1 Late membrane exposure without infection Class II Minor

6–9 months 20 0 - - -
 17088208, 2017, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.12520, Wiley Online Library on [10/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
CUCCHI ET AL. | 829

TA BL E 2 Complication rate and type in group B

Timing N. patients N. complications Complications features Complication class Complications type

0–1 month 19 2 -Abscess without exposition Class IV Major

-Early exposure with infection Class III Major

1–3 months 19 1 Late exposure with infection Class III Major

3–6 months 19 1 Late exposure without infection Class II Minor

6–9 months 19 0 - . .

implants, all graft biomaterials, and PFTE membranes were removed to can affect new bone formation more than can late exposure.16,46,47 In
resolve the infection. No loss of pre-existing bone occurred. The latter this study, device exposure during the first 4 postoperative weeks in
involved no infection, and the newly formed bone was not affected. As both groups resulted in incomplete bone regeneration or total failure
reported by others, even major complications in GBR procedures, of the regenerative procedures. In contrast, late exposure of the barrier
unlike other bone augmentation techniques, typically do not affect the devices did not influence bone regeneration in either group.
initial bone volume 48–49. In Group B, one case of abscess without In terms of Ti mesh, a positive association of time and extent of
exposure, one early exposure with infection, one late exposure with device exposure with newly formed bone resorption has been estab-
infection, and one late exposure without infection were observed. lished.44 In the case of Ti mesh exposure, the lack of bone volume was
Only the latter complication was considered a minor complication significantly positively correlated with the area of mesh exposed, with
because the others markedly affected the newly formed bone. In two a 16.3% deficit in bone volume for every cm2 of mesh exposed. Addi-
cases, all implants, all graft biomaterials, and the PFTE membranes tionally, there were positive associations of the lack of bone volume
were removed; however, in the case of late exposure with infection, and early exposure with planned bone volume.44
only the Ti mesh was removed, which maintained all implants in situ, In this study, the surgical complications involved one case of tem-
and the restoration was completed with a definitive prosthesis. porary paresthesia for d-PTFE membranes and three for Ti mesh plus
Considering the types of complications, major complications were collagen membranes, yielding rates of 5% and 15.8%, respectively. This
seen in 10% and 15.8% for d-PTFE membranes and Ti mesh, respec- difference was not statistically significant. All surgical complications
tively; no statistically significant difference was observed between the belonged to Class B19 and recovered within 1 month after GBR sur-
groups. The complications that occurred in this study are similar to those gery. These nerve injuries were probably caused by stretching of the
reported in the literature describing barrier device exposure and infec- mental nerve during flap passivation. Moreover, this class of complica-
tion as frequent problems associated with this technique.5,40,41,43–45 tion is often related to the need for extensive flap management to
In particular, there have been reports of a range of barrier device achieve a tension-free closure over the barrier device.12,13,19 Another
5 41,45
exposures: between 0% and 45% and between 12% and 50% for cause of nerve injuries involves management of the barrier device: dur-
PTFE membranes and Ti mesh, respectively. The results of this study ing bone augmentation surgery, d-PTFE membranes were shaped,
are close to those reported by Simion et al. and Roccuzzo et al.,40,41 adapted, and stabilized more readily and quickly than were the Ti mesh
who reported rates of exposure of 12% and 22% for PTFE and Ti devices. Additionally, during the reopening surgery, Ti mesh required
mesh, respectively. more time and more effort than did the non-resorbable membranes.
The significance of membrane exposure for the successful out- Thus, the latter showed better manageability and ease of use and
come of GBR procedures has been much debated. Several studies have required less dexterity and fewer manual skills.
shown that the onset of exposure is important for the success of the Regarding VBG, the effectiveness of GBR for the resolution of ver-
procedure. In fact, some authors have demonstrated that “premature” tical and horizontal bone defects has been demonstrated in short- and
exposure (during the first 4 postoperative weeks) of the barrier device long-term studies.5,19,43,48 We showed mean bone gains of 4.2 and

TA BL E 3 Peri-implant bone defect and vertical bone gain in TA BL E 4 Peri-implant bone defect and vertical bone gain in
Group A Group B

Peri-implant bone Peri-implant bone Vertical bone Peri-implant bone Peri-implant bone Vertical bone
Site defect T0 (mm) defect T1 (mm) gain T1 (mm) Site defect T0 (mm) defect T1 (mm) gain T1 (mm)

Mesial 3.2 6 0.9 20.5 6 0.6 3.6 6 1.2 Mesial 3.1 6 0.9 20.4 6 0.7 3.3 6 1.0

Lingual 3.6 6 0.9 20.6 6 0.6 4.2 6 1.2 Lingual 3.4 6 0.8 20.4 6 0.6 3.8 6 0.8

Distal 3.5 6 0.8 20.7 6 0.6 4.1 6 1.0 Distal 3.8 6 1.0 20.4 6 0.6 4.0 6 1.0

Buccal 4.8 6 0.7 20.3 6 1.0 5.0 6 1.0 Buccal 5.7 6 1.6 20.4 6 1.5 5.1 6 1.4

Mean 3.8 6 0.7 20.5 6 0.6 4.2 6 1.0 Mean 4.0 6 0.8 20.2 6 0.7 4.1 6 1.0
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830 | CUCCHI ET AL.

4.1 mm for d-PTFE membranes and Ti mesh plus collagen membranes, stability over time.7,12,46,54–57 The preliminary results of this study do
respectively. There were no significant statistically differences, confirm- not permit us to draw a conclusion in this regard. A longer follow-up
ing the effectiveness of both devices for bone regeneration in the pos- period after the definitive loading is needed to observe any significant
terior atrophic mandible. difference between d-PTFE membranes and Ti mesh plus collagen mem-
Additionally, in both groups, a low percentage (< 20%) of partial branes with regard to peri-implant bone stability and crestal bone loss.
bone regeneration with a residual peri-implant bone defect was
recorded. The findings presented here are similar to reports in the liter- 5 | CONCLUSIONS
ature. Simion et al. in 2007,25 reported a mean VBG with PTFE mem-
branes of 3.85 mm. These results were confirmed by the systematic The preliminary results of this randomized controlled trial showed that
review performed by Milinkovic e Cordaro in 2014,49 which reported d-PTFE membranes and titanium mesh plus collagen membranes pro-
an average VBG of 3.04 mm with a one-stage GBR approach with non- duced similar results in terms of healing complication types and rates.
resorbable membranes. The mean complication rate was 13.1%, and In contrast, d-PTFE membranes showed a lower rate of surgical compli-
these cases were usually related to membrane exposure.49 Similarly, in cations. In both groups, similar vertical bone gain (VBG) and bone for-
2004, Roccuzzo et al.50 reported a mean VBG of 4.8 (range, 4–7) mm mation were achieved, with no complications occurring, confirming the
after Ti mesh reconstructive surgery. Ricci et al.,51 reported a mean reliability and effectiveness of guided bone regeneration (GBR) for
VBG of 4.16 6 0.59 mm, with a healing complication rate of 22.8% for restoring the atrophic posterior mandible. Finally, the use of double-
the Ti mesh approach.51 In this study, a one-stage reconstructive variable tapered implants seemed to be reliable in both immediate GBR
approach was used in both groups. approaches.
Regarding the timing of implant placement, there is evidence to
support the use of GBR at the time of implant placement and before
AC KNOWLEDG MENT S
implant placement when a peri-implant bone defect is pres-
The authors are grateful to Clarisciences for the descriptive and ana-
ent.7,12,13,20,25,41,51 Additionally, some reports comparing one-stage
lytical statistical analyses. The English in this document has been
and two-stage approaches did not detect any statistically significant
43,51,52 checked by at least two professional editors, both native speakers of
differences in VBG, with values of 4.5 mm in both. When a one-
English. For a certificate, please see: http://www.textcheck.com/
stage procedure is performed, high primary implant stability is required.
certificate/DtZXwp
In this study, implants in both groups showed high IT and RFA torque
values, probably due to the implant characteristics: specifically, the
double-variable thread design. In atrophic posterior mandibles, the sta- CONFLIC T OF I NTE RE ST
bilization of implants can be difficult because of the reduced bone vol- None
ume available above the mandibular canal.
Implant placement occurred simultaneously with bone augmenta- RE FE RE NCE S
tion, whereas and functional loading was delayed until 3–4 months
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