Open Membrane Technique as an Innovative Minimally Invasive Technique

Not Applicable

Completed

• Conditions: Keratinized Tissue; Bone Graft

• Registration Number: NCT06134869
• Lead Sponsor: Saint-Joseph University

Brief Summary

Sixteen patients with horizontal deficiencies in the posterior mandible were treated with "the Open Membrane Technique" (OMT). Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap. Flap closure with an open wound (membrane exposure) was monitored weekly for up to 6w at the time of membrane removal. At implant placement, soft and hard tissue gains were assessed clinically and radiographically. Bone cores were harvested for histological analysis from the implant preparation sites

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-08-10
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy adults
• Free of any systemic disease affecting bone metabolism
• Highly compliant
• Good oral hygiene
• Willing to sign informed consents prior to their inclusion

Exclusion Criteria

• Untreated periodontal disease
• Heavy smokers
• Excessive alcohol consumption
• Uncontrolled systemic conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hard tissue gain	5 months	Bone thickness measured clinically and on CBCT (during bone grafting and at re-entry)

Secondary Outcome Measures

Name	Time	Method
Soft tissue gain	5 months	Keratinized tissue measured clinically before and after the treatment (at implant placement)

Trial Locations

Locations (1)

Clinic 506; 🇱🇧 Beirut, Ashrafieh, Lebanon