Lateral GBR Using Two Types of Membrane With a Combination of Allograft-xenograft

NCT07525128 | Active Not Recruiting Phase 4 DMC FDA Device

• 1 other identifier: CER-2025-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Bone width is critical for successful implant placement, as thin bone increases the risk of bone loss. Various augmentation techniques-especially guided bone regeneration (GBR)-are effective in restoring bone volume using grafts and barrier membranes. Collagen membranes are commonly used but degrade quickly, leading to the development of improved types like porcine peritoneum membranes, which show better strength and durability. While autogenous grafts are the gold standard, combining different graft materials (e.g., xenograft and allograft) has shown promising results. However, no studies have directly compared porcine peritoneum membranes with cross-linked membranes using such graft combinations. This study aims to evaluate and compare their effectiveness in increasing bone width.

Conditions

Guided Bone Regeneration; Bone Augmentation

Keywords

Lateral guided bone regeneration

Outcome Measures

Primary Outcomes (1)

• Compare the linear and volumetric bone width changes, clinically and radiographically, between two different membranes : glutaraldehyde cross-linked collagen membrane and a peritonium-derived membrane with the use of a bone graft combination of demineral

  From March 2025 to March 2026

Study Arms (2)

Peritoneun Collagen Membrane group

ACTIVE COMPARATOR

Peritoneum Collagen Membrane group with a combination of allograft and xenograft

Procedure: Lateral Guided bone regeneration

Cross-linked bovine type 1 Collagen Membrane group

ACTIVE COMPARATOR

Cross-linked bovine type 1 Collagen Membrane group with a combination of allograft and xenograft

Procedure: Lateral Guided bone regeneration

Interventions

Lateral Guided bone regeneration PROCEDURE

Lateral guided bone regeneration using two types of membranes

Cross-linked bovine type 1 Collagen Membrane group; Peritoneun Collagen Membrane group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients aged 20 to 75 years.
• Healthy individuals, either non-smokers or smokers consuming fewer than 10 cigarettes per day.
• Full mouth bleeding score (FmBS) below 20%.
• Full mouth plaque score (FmPS) below 15%.
• Presence of a residual alveolar ridge with a bone width of less than 6 mm but sufficient bone height in the maxilla or mandible.
• Tooth extraction must have been performed at least six weeks prior to surgery.
• Adequate number of teeth to allow for the use of an occlusal stent or radiographic guide.

You may not qualify if:

• \- Presence of systemic illnesses.
• Smoking more than 10 cigarettes per day.
• Underwent radiotherapy in the head or neck region within the past 5 years.
• Active periodontitis affecting the remaining teeth.
• Pregnancy.
• Use of medications that could impact bone turnover or mucosal healing, such as tetracycline in the last month, steroids within the past 6 months, bisphosphonates, therapeutic doses of fluorides, or vitamin D and its metabolites within the last 6 months.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University of Beirut , Campus of Medical Sciences

Beirut, Beirut, 10001111, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: March 10, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

LE (1)