Open Membrane Technique as an Innovative Minimally Invasive Technique

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

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

Study Overview

• Status: Completed
• Conditions: Bone Graft; Keratinized Tissue
• Intervention / Treatment: Procedure: Bone augmentation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Ashrafieh
    • Beirut, Ashrafieh, Lebanon
      • Clinic 506

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hard tissue gain	Bone thickness measured clinically and on CBCT (during bone grafting and at re-entry)	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue gain	Keratinized tissue measured clinically before and after the treatment (at implant placement)	5 months

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: USJ-2023-241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any data will be shared with other researches if it is required or will help conducting further studies.
• IPD Sharing Time Frame: The data are available at any time
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No