Open Membrane Technique as an Innovative Minimally Invasive Technique

Bone Graft Clinical Trial

Official title:

Open Membrane Technique as an Innovative Minimally Invasive Technique for Hard and Soft Tissue Augmentation: a Prospective Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06134869
• Other study ID #: USJ-2023-241
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2023
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Graft

Intervention

Procedure:
• Bone augmentation
Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap

Locations

Country	Name	City	State
Lebanon	Clinic 506	Beirut	Ashrafieh

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hard tissue gain	Bone thickness measured clinically and on CBCT (during bone grafting and at re-entry)	5 months
Secondary	Soft tissue gain	Keratinized tissue measured clinically before and after the treatment (at implant placement)	5 months