Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID07254494

Comparative Evaluation of Resorbable (Pericardium) Versus Non Resorbable (Polytetrafluoroethylene) Membrane for Horizontal Bone Augmentation of Posterior Atrophic Mandible

Led by Beirut Arab University · Updated on 2025-11-28

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the effectiveness of non-resorbable membranes versus resorbable membranes in guided bone regeneration for patients with bone loss in the lower back part of the jaw (posterior mandible). This study addresses challenges like bone loss due to periodontal disease, tooth extraction, or prolonged use of dentures, which can make implant placement difficult. The goal is to improve bone regeneration methods in this area to support dental implants. Participants will receive one of two treatments: either a resorbable pericardium membrane or a non-resorbable polytetrafluoroethylene (PTFE) membrane. Both membranes will be fixed with titanium pins or tacks to the jawbone, covering a mix of bone graft material made of half xenograft and half autogenous bone. The graft is overfilled to account for future resorption and covered tightly by the membrane to stabilize and promote new bone growth. Throughout the study, participants will undergo clinical and radiographic exams including CBCT scans before and six months after surgery to measure bone thickness, height, and gain. Postoperative pain and discomfort are tracked with questionnaires for seven days. After six months, a biopsy will be taken to analyze new bone formation. Complications such as infections, membrane exposure, and implant stability will also be monitored. The study lasts at least one year with follow-up visits to assess outcomes.

CONDITIONS

Brief Title

Guided Bone Regeneration in Lower Posterior Edentulous Arch Using Resorbable or Non Resorbable Membrane.

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mandibular posterior atrophic alveolar ridge requiring horizontal bone augmentation before implant placement
  • Alveolar bone height suitable for implant placement
  • Free of any local or systemic condition that may contraindicate ridge expansion procedure
  • Ability to understand and accept the study conditions
  • Willingness to participate in follow-up for at least one year
Not Eligible

You will not qualify if you...

  • Heavy smokers (2 or more packs of cigarettes per day)
  • Insufficient oral hygiene
  • Acute local or systemic infection
  • Any systemic disease that may affect bone healing
  • Pregnancy or possibility of becoming pregnant during the study
  • Addiction to drugs or alcohol

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single surgical procedure with postoperative care

Participants will undergo guided bone regeneration surgery using either a resorbable pericardium membrane or a non-resorbable polytetrafluoroethylene (PTFE) membrane to augment the atrophic posterior mandible. This includes bone grafting and membrane fixation followed by postoperative care including medications and instructions.

1 surgical visit and multiple postoperative follow-up visits during the first week

Follow-up

Duration - 6 months

Participants will have follow-up assessments including radiographic imaging and clinical evaluation to monitor bone regeneration and implant stability. After 6 months, the site will be re-opened for membrane removal if non-resorbable membrane was used, bone biopsy collection, and dental implant placement.

At least 2 visits (around 6 months post-surgery) plus weekly visits for pain and discomfort monitoring during the first postoperative week

Trial Site Locations

Total: 1 location

1

Beirut arab university

Beirut, Lebanon, 0000

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Research Team

H

hiba A alrifaii, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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