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

NCT07254494 | Recruiting

• 1 other identifier: 2025-H-0161-D-M-0692
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Horizontal Alveolar Bone Defect; Guided Bone Regeneration

Keywords

atrophic; horizontal bone loss; guided bone regeneration; pericardium membrane; PTFE membrane; resorbable membrane; non resorbable membrane; GBR

Outcome Measures

Primary Outcomes (2)

• Osstell Implant Stability Quotient (ISQ)

  measure the implant stability in both group using osstell machine ,The ISQ scale ranges from 1 to 99, with higher values indicating greater stability

  6 months after the surgery at the time of implant placement

• change from baseline in pain as measured by the visual analogue scale VAS

  pain sensation measured by VAS visual analogue scale score of both group the VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain. scores are measured on a 100 mm VAS

  baseline,12 weeks

Secondary Outcomes (2)

• Horizontal bone gain measured using CBCT in mm

  6 months

• Qualitative bone assessment using histological and histomorphometric analysis to measure the % of bone

  6 months

Study Arms (2)

guided bone regeneration using Resorbable membrane pericardium

EXPERIMENTAL

A resorbable pericardium membrane will be fixed with titanium pins on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption. The membrane will be stretched over the graft ensuring maximum immobilization of the graft.

Procedure: guided bone regeneration using Resorbable membrane pericardium

guided bone regeneration using non resorbable membrane polytetrafluoroethylene PTFE

EXPERIMENTAL

A non-resorbable polytetrafluoroethylene (PTFE) membrane will be fixed with titanium tacks on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption.

Procedure: guided bone regeneration using non resorbable ptfe membrane

Interventions

guided bone regeneration using Resorbable membrane pericardium PROCEDURE

A resorbable pericardium membrane will be fixed with titanium pins on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption. The membrane will be stretched over the graft ensuring maximum immobilization of the graft.

guided bone regeneration using Resorbable membrane pericardium

guided bone regeneration using non resorbable ptfe membrane PROCEDURE

A non-resorbable polytetrafluoroethylene (PTFE) membrane will be fixed with titanium tacks on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption.

guided bone regeneration using non resorbable membrane polytetrafluoroethylene PTFE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mandibular posterior atrophic alveolar ridge Required horizontal bone augmentation procedures prior to implant placement.
• Alveolar bone height suitable for implant placement.
• Free of any local or systemic condition that may contraindicate ridge expansion procedure
• The capacity to understand and accept the conditions of the study.
• Continuing participation over at least 1 year of follow-up.

You may not qualify if:

• Heavy smokers (i.e., 2 or more packs of cigarettes per day);
• Insufficient oral hygiene
• Acute local or systemic infection
• Patients with any systemic disease that may affect bone healing;
• Pregnancy or the possibility of becoming pregnant during the study; and
• Addiction to drugs or alcohol

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut arab university

Beirut, 0000, Lebanon

RECRUITING

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

hiba A alrifaii, BA

CONTACT

96171693913; haa135@student.bau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: oral pathologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: November 28, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning \[e.g., 6 months\] after publication and continuing for \[e.g., 2 years\].

Locations

LE (1)