Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

Study Overview
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Brief Summary
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This randomized clinical trial (RCT) study investigates if there is any difference in complication rate between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane. The primary endpoint is complication rate. The secondary endpoints are regeneration rate and pseudoperiosteum formation.

Official Title
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Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial

Conditions
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Bone Regeneration, Dental Implants, Polytetrafluoroethylene

Intervention / Treatment
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* Procedure: Guided bone regeneration with a PTFE membrane
* Procedure: Guided bone regeneration with a PTFE+collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partially edentulous patients requiring vertical and horizontal ridge augmentation patients agrees with conditions of the study and sign consent Exclusion Criteria: Insufficient oral hygiene Smoking Alcohol or Drug abuse acute local or systemic infections uncontrolled diabetes or other metabolic disease severe hepatic or renal disfunction autoimmune disease radiotherapy in the last 5 years patients receiving immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ridge Augmentation with a perforate PTFE mesh<br>Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The graft material is autograft mixed with a xenograft in a 1:1 ratio. | Procedure: Guided bone regeneration with a PTFE membrane<br>* Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws.<br>|
| Experimental: Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane<br>Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The mesh will be covered with a native collagen membrane. The graft material is autograft mixed with a xenograft in a 1:1 ratio. | Procedure: Guided bone regeneration with a PTFE+collagen membrane<br>* Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance, | 9 months | 
| Bone gain | Vertical and horizontal bone gain measured | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Bone Regeneration, Vertical Ridge Regeneration, PTFE membrane