Open Membrane Technique as an Innovative Minimally Invasive Technique

Sponsor

Saint-Joseph University (Other)

Overall Status

Completed

CT.gov ID

NCT06134869

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bone Graft Keratinized Tissue	Procedure: Bone augmentation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients requiring horizontal bone augmentation in the posterior mandible	Procedure: Bone augmentation Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap

Arm

Intervention/Treatment

Other: Patients requiring horizontal bone augmentation in the posterior mandible

Procedure: Bone augmentation

Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Soft tissue gain [5 months]
Keratinized tissue measured clinically before and after the treatment (at implant placement)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic 506	Beirut	Ashrafieh	Lebanon

Sponsors and Collaborators

Saint-Joseph University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdel Rahman Kassir, Clinical Professor, Saint-Joseph University

ClinicalTrials.gov Identifier:

NCT06134869

Other Study ID Numbers:

USJ-2023-241

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2023