Comparative Evaluation of Resorbable (Pericardium) Versus Non Resorbable (Polytetrafluoroethylene) Membrane for Horizontal Bone Augmentation of Posterior Atrophic Mandible
Phase: NA
Conditions: Horizontal Alveolar Bone Defect, Guided Bone Regeneration
Sponsor: Beirut Arab University

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COMPARATIVE EVALUATION OF RESORBABLE (PERICARDIUM) 
VERSUS NON RESORBABLE MENBRANE 
(POLYTETRAFLUOROETHYLENE) FOR HORIZONTAL BONE 
AUGMENTAITON OF POSTERIOR ATROPHIC MANDIBLE.  
(Randomized Controlled Trial) 
 تقييم مقارن لل غشاء 
 القابل لالمتصاص (التامور) مقابل لل غشاء 
 )غير القابل لالمتصاص (بولي تترافلورو إيثيلين
 لزيادة العظام افقيا 
 للفك السفلي الخلفي .
  
 ( د )راسة سريرية عشوائية محكمة 
By 
Hiba Abdelkarim AlRifaii 
Thesis 
Submitted in Partial Fulfillment of the Requirements for the Degree 
of Master in Periodontology 
Department of Periodontology 
Faculty of Dentistry 
2024 
 

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Abstract 
Background: Deficient bony ridges often complicate the implant treatment plan. Several treatment 
modalities are used to regenerate bone, including guided bone regeneration (GBR). The purpose of 
this study is to compare the effect of two types of membrane, resorbable and non- resorbable used 
in GBR for horizontal bone augmentation in atrophic posterior mandible.  
Aim of the study: the aim is to compare the outcome of the resorbable pericardium membrane and 
the non-resorbable PTFE membrane in GBR in staged approaches, in terms of clinical outcome, 
new bone quality and quantity radiographically and histologically.  
Material and methods: A randomized controlled clinical trial was designed,20 patients with 
mandibular atrophic ridge will be randomly divided into 2 groups. Both groups will be treated with 
a staged approach. 10 patients will be treated with GBR by means of non-resorbable d-PTFE 
titanium reinforced membrane (Group A). and the other 10 patients, by means of pericardium 
membrane (Group B). Both groups will be grafted by a mixture of xenograft and autograft. All the 
clinical and radiographic evaluation will be recorded.  After 6 months in the second stage, a CBCT 
radiograph will be taken, and implants will be placed after taking a bone specimen for histological 
studies.  
Results: data will be collected, tabulated, and statistically analyzed using appropriate tests 
Keywords: GBR, pericardium membrane, PTFE membrane, alveolar ridge reconstruction, 
atrophy. 
 
 
 
 
 
 
 
 

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Introduction 
Lack of adequate bone for implant placement due to a previous history of periodontal disease, 
traumatic tooth extraction, or bone loss from prolonged use of a removable prothesis, is a common 
challenge in implant dentistry (Soldatos NK et al ,2017).  Bone loss after tooth extraction has been 
reported to range between 40% and 60% during the first 3 years, and thereafter it is estimated to 
range between 0.25% and 0.5% annually (Helmi MF,et  al,2019). 
Alveolar atrophy refers to the pathological condition where there is moderate to severe resorption of 
alveolar bone due to tooth loss (Tsuchida Set al 2023). When teeth are lost, the functional stimulus 
for the alveolar bone is also lost, leading to predictable bone resorption (Jonasson G et al ,2018).  
The pattern of resorption varies based on location, where in the mandible, alveolar bone resorption 
is primarily horizontal, while in the interforaminal regions, it tends to be centripetal and in 
retroforaminal areas, the resorption is vertical and centrifugal. (Tsuchida Set al 2023). The presence 
of the inferior alveolar nerve (IAN) further complicates treatment in the posterior regions of the 
mandible when using Osseo integrated implants. These challenges necessitate careful planning and 
consideration during implant placement to achieve successful outcomes. (Tsuchida Set al 2023) 
Various methods are employed to regenerate bone in areas with deficiencies, including using 
autogenous or allogeneic block grafts (cortical, cancellous, or cortico-cancellous), ridge splitting 
techniques, distraction osteogenesis, orthodontic tooth movement, and guided bone regeneration 
(GBR) with or without additional filler materials. (Toscano N, et al 2010). 
 
Numerous materials have been utilized for bone regeneration, with ongoing research in this field to 
address bone defects. Particularly in the context of widespread implant usage, various options such 
as autogenous bone, allogeneic bone, and synthetic bone have been employed to treat oral and 
maxillofacial bone defects (Ferraz MP et al ,2023). Although fresh autogenous bone yields optimal 
regeneration results due to its osteoinductive and osteoconductive properties, it comes with 
drawbacks like pain and edema from donor site injury, limited harvest volume, and high graft 
resorption rates. Consequently, allogeneic bone graft materials, lacking inherent bone regenerative 
capacity but obviating the need for an additional donor site, have gained significant use. However, 
due to their source from other individuals, these tissues may provoke an immune response in 
recipient tissues, posing a potential antigenic challenge. (Tang G, Liu Z, Liu Y, et al,2021) 

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Barrier membranes play a crucial role in guided bone regeneration (GBR), with various types being 
utilized resorbable (pericardium collagen …) and non-resorbable membrane. (e-PTFE,d-PTFE….). 
Polytetrafluoroethylene (PTFE) serves as the foundational material for the most prominent and 
earliest non-absorbable membranes used clinically. This substance is derived from an unbranched, 
linear, semi-crystalline polymer comprising a combination of fluorine and carbon. PTFE falls under 
the category of polyhaloolefins and is classified as a thermoplastic material. Additionally, it is widely 
regarded for its high inertness. Titanium-reinforced membranes have been created to overcome this 
deficiency. A titanium skeleton with high strength and stiffness is inserted into the PTFE membrane 
to give it excellent plasticity and volume stability. (Kameda T, Ohkuma K, Oka S, 2018) 
Several types of PTFE membrane have been introduced (e-PTFE and D-PTTFE). The e-PTFE 
membrane promotes tissue cell attachment and stabilizes wounds by having small pores that limit 
the migration of connective tissue and epithelial cells (Qiang Guo et al 2022). However, its exposure 
to the oral cavity increases the risk of bacterial penetration and often requires premature removal, 
which can negatively impact outcomes (Ghensi P et al ,2017). Resorbable membranes have a higher 
rate of resorption after exposure, leading to potential adverse effects. The ability of the e-PTFE 
membrane to attach to tissue often necessitates a second surgery for removal. Consequently, non-
resorbable membranes are now widely used instead of e-PTFE membranes (Sasaki JI et al 2021). 
The use of d-PTFE in dentistry is gaining acceptance due to its smaller pore size, reducing the risk 
of bacterial contamination when left exposed in the oral cavity. d-PTFE membranes effectively 
maintain space, stabilize wounds, and allow sufficient time for bone regeneration. Their non-
attachment to tissue enables removal through the mucosal flap without causing trauma. Nevertheless, 
due to limited porosity, adequate blood supply to the area relies on marrow space and cortical 
perforations for successful bone regeneration (Ghensi P et al ,2017). 
 
At present, titanium-reinforced membranes have become a well-established foundational material 
for creating stable volumes conducive to osteogenic space, thereby facilitating bone tissue 
regeneration in clinical settings (Windisch P et al 2021). According to a recent meta-analysis, 
titanium-reinforced d-PTFE emerged as the optimal choice for guided bone regeneration (GBR) or 
guided tissue regeneration (GTR), as it demonstrated the highest vertical bone regeneration potential 
coupled with a low incidence of complications (Windisch P et al 2021). 

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Hence, absorbable membranes that can mimic the effects of nonabsorbable ones have gained recent 
attention. For instance, we opted for pericardium, an absorbable membrane derived from human 
pericardial tissue (Ren Y et al 2022).  
The pericardium is a sac made of fibrous and serous tissues that envelops the heart in mammals. It 
has been extensively utilized in cardiac surgery for tasks such as reconstruction, repairing valves, 
and closing the pericardial layer. Pericardial tissue is renowned for its excellent handling properties 
and consistent ability to retain sutures (Waleed, Mohamed, Abbas., D., A., Khalik,2023). 
Furthermore, it possesses innate qualities that make it resistant to thrombosis and infection. 
Xenogeneic pericardium, sourced mainly from bovine and porcine origins, and occasionally from 
equine sources, is commonly used. These tissues are available in large patches, allowing for 
customized shaping to suit various cardiovascular procedures. Predominantly composed of collagen 
fibers, xenogeneic pericardium possesses elastic properties, enabling it to adapt to intricate 
anatomical structures. (Tristan, 2020)  
The selection of an appropriate tissue barrier involves considering various properties of the 
pericardium 
membrane. 
These 
include 
its 
physical 
characteristics, 
biocompatibility, 
biodegradability, immunogenicity, capacity to attract and stimulate periodontal ligament fibroblast 
cells, as well as its ability to promote adherence and proliferation of regenerative cells. Additionally, 
the membrane's potential to effectively seal the underlying defect is crucial for its success. 
Pericardium membranes have demonstrated strong crosslinking, suggesting a longer duration for 
resorption. (Jéssica, Suzuki etal 2022). 
Additionally, the pericardium membrane provides a scaffold for attachment, migration, and 
proliferation of periodontal ligament fibroblasts, thereby promoting regeneration of soft tissues. As 
part of guided bone regeneration, the pericardium membrane facilitates the release of growth factors 
and preserves blood supply to the affected area, thereby promoting growth of bone and soft tissue 
and enabling regeneration of periodontal tissues. (Ernie et al ,2020). 
Pericardium has found widespread use in regenerating bone defects around implants or serving as a 
barrier membrane for maxillary sinus perforations. However, there remains a scarcity of clinical 
studies assessing these procedures. (Tsuchida Set al 2023). 

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In this context, the purpose of this study is to compare the efficiency of non-resorbable membrane 
versus resorbable membrane in guided bone regeneration in atrophic posterior mandible.  
Null hypothesis is that there is no significant difference between the pericardium and the d-PTFE 
membrane.  
Aim of the study: 
The primary objective of this study is to evaluate and compare clinically, radiographically, and 
histologically the efficiency of native pericardium porcine collagen membrane (Botiss Jason®) 
versus d-PTFE non resorbable membrane for horizontal augmentation of alveolar ridge for patients 
with posterior mandibular atrophy.  
Plan of the study: 
Study design: This study will be carried out as a randomized controlled clinical trial following 
CONSORT guidelines.  
Study setting: 
Eligibility criteria  
Twenty partially edentulous patients with horizontal bone deficiency in the posterior mandibular 
ridge requiring bone augmentation and implant-supported restoration who will be referred to the 
Periodontal department in the faculty of dentistry at Beirut Arab university, Lebanon, will be 
included in the protocol. Subjects will be randomly assigned to one of 2 groups: controls (group 
A:10) who will receive GBRB using d-PTFE barrier, and experimental (group B:10) who will 
receive GBR using native pericardium collagen membrane. Subjects from both groups will be treated 
with the selected barrier and the underlying space-making composite graft of xenograft plus 
autogenous bone to help support the overlying membrane. 
 

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Inclusion criteria: 
1. Both males and females of age 18 years or older 
2. Mandibular posterior atrophic alveolar ridge Required horizontal bone augmentation 
procedures prior to implant placement. 
3. Alveolar bone height suitable for implant placement.  
4. Systemically healthy. 
5. The capacity to understand and accept the conditions of the study. 
6. Continuing participation over at least 1 year of follow-up. 
Exclusion criteria 
1. Heavy smokers (i.e., 2 or more packs of cigarettes per day); 
2. Insufficient oral hygiene 
3. Acute local or systemic infection 
4. Systemic conditions such as diabetes, hyperparathyroidism, osteoporosis, severe liver or 
kidney condition, active sinusitis, cancer, and use of immunosuppressive agents or 
corticosteroids, any autoimmune disorder, and/or bisphosphonate therapy. 
5. Pregnancy or the possibility of becoming pregnant during the study; and  
6. Addiction to drugs or alcohol 
Patients who meet the inclusion criteria will be informed about the objectives and conditions of the 
study. Each patient will receive written information and provide written informed consent before 
participation in any study‐related procedure. After enrollment, each patient will receive a unique 
identification number, according to which all data will be recorded. Patients will be blinded and 
will not know the assigned study group. 
 
 
 
 

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Material and methods 
Material  
- 
Xenograft* 
- 
Pericardium membrane* 
- 
d-PTFE membrane* 
- 
PGA suture 4-0 
- 
PTFE sutures 4-0 
Methods   
All the patients will be subjected to the pre surgical phase which include:  
1. Patient history: 
a. Personal history  
b. Past medical and dental history  
 
2. Clinical and radiographic examination  
a. Both extra and intra oral examination will be done  
b. A routine panoramic x-ray for patient selection  
c. A CBCT x-ray for preoperative implant site assessment   
 
3. Phase 1 therapy: 
a. Plaque control education: 
i. Diet control (in patient with rampant caries) 
ii. Removal of calculus and root planning  
iii. Correction of restorative and prosthetic irritation factors  
 
*  
* Jason® Collagen Membrane 
* Cytoplast™ Ti-Reinforced Membrane 

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iv. Excavation of caries and restoration (temporary or final, depending on 
whether a definitive prognosis for the tooth has been determined and location 
of caries)  
v. Antimicrobial therapy (local or systemic if needed)  
b. Each patient will undergo oral hygiene measures such as electronic scaling, 
polishing and mouthwash usage for a couple days. 
 
4. Surgical phase  
a. Patient preparation:  
• Extraoral scrubbing with 5% povidone-iodine solution. 
• The patient’s mouth will be rinsed with a solution of chlorhexidine digluconate 0.2% for 2 
minutes.  
 
b. Surgical procedures  
STAGE 1 
• A local anesthetic will be administered using 4%lidocaine hydrochloride. 
• A mid‐crestal horizontal incision within the keratinized tissue of the edentulous ridge. 
• A vertical incision will be made to coronally advance the flap.  
• A periosteal release of the flap will be performed. 
• A dissection will be made to remove the tension and muscle fibers in the flap in order to 
have a tension free and a coronally advanced flap. 
• Cortical perforations will be made with #8 round bur. 
• 8-mm tenting screws will be placed with 3 mm incorporated into the bone. 
• Bone harvesting using a bone scraper. 
• Creation of 50:50 bone mixtures of xenograft and autogenous bone placement 
• Lingual fixation of ti-reinforced d-PTFE membranes (cytoplast ti-250xl; osteogenics 
biomedical) in group A or fixation of pericardium native collagen membrane (jason 
membrane) in group B. 
• Filling and adaptation of the biomaterial mixture under the membrane.   
• Buccal-side fixation using two or three mini-screws (pro-fix membrane fixation screws) 

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• Free-tension primary closure using double-line suturing by PTFE (4-0) sutures, and PGA 
sutures (4-0 and 6-0) 
• Written postoperative instructions and medications will be given to the patients. These include 
amoxicillin 500 mg tablets, hydrocodone/APAP 10/325, 0.12% chlorhexidine solution, and 
ibuprofen 600 mg, chlorhexidine gluconate mouth rinse (0.12% t.i.d.), and topical 
chlorhexidine 4 times per day applied to the surgical site. 
CLINICAL EVALUATION 
1. Swelling will be rated on a 0–3 scale (0, none; 1, minor; 2, moderate; 3, severe) 
2. Healing of tissues: will be  evaluated by the presence or absence of pus, color of overlying mucosa, 
and presence or absence of dehiscence within the flaps. 
3.  ⁠Pain was evaluated according to the Visual Analogue Scale (VAS), on the 2nd, 7th and 14th 
postoperative days (Coulthard, et al., 2014) 
4. Paresthesia was evaluated according to the Two Point Discrimination Test (TPD) (Meshram, et al., 
2013) on the 4th, 7th and 14th postoperative days 
 
RADIOGRAPHIC ASSESSMENT: 
• CBCT will be done preoperatively, immediate postoperative and 6 months postoperative. 
• The buccolingual dimension will be recorded.  
 
 
STAGE 2 
• After 6 months, all treated sites will be reopened for barrier removal in group A and screw 
removal in group B and implant placement.  
• Bony tissue biopsies were taken using a 3-mm-diameter trephine bur at the sites of implant 
placement.  
• A unique identification number will be assigned to each biopsy specimen to blind the single 
operator who performed all histological and histomorphometric analyses. 

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• After two to three more months, the stage-two surgery will be performed, and the case will be 
referred to the restorative dentist for the final restoration. 
 
HISTOLOGICAL AND HISTOMORPHOMETRIC ANALYSES 
• Bone biopsies will be fixed in 10% (v/v) phosphate-buffered formalin followed by 
decalcification. 
• After decalcification, the samples will be dehydrated in a graded series of alcohol baths and 
embedded in paraffin. 
•  Histological sections 5-μm-thick will be prepared using the microtome (Microm International 
GmbH, Heidelberg, Germany) and stained with hematoxylin/eosin to display cytoplasmic, 
nuclear, and extracellular matrix features.  
• The ImageJ software (U.S. National Institutes of Health, Bethesda, Maryland) will be used to 
perform histomorphometric analyses.  
• To this end, careful microscopic evaluation of each entire biopsy will be measured: 
o  bone tissue area (B.Ar) 
o  graft material area (Mat. Ar), 
o  soft tissue area (St.Ar), 
o  All variables will be expressed relative to the total area (Tot.Ar) as percentage.  
 
 
 
 
 
 
 

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Ethical guidelines: 
Ethical research committee approval  
Approval of the ethical committee of the faculty of dentistry, Beirut Arab university, Lebanon. 
Must be obtained prior to the study.  
Informed consent: 
The objectives, risks and benefits of the study are to be explained to the patient s and a signed 
informed consent is to be required before the treatment can commence.  
Participants safety  
Biosafety principles are mandatory during the entire treatment procedures. Patients are informed 
about all the possible clinical and or adverse outcomes and they will be required to be reported if 
any of them occur on spot.  
 
 
 
 
 
 
 
 
 
 

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