Open Membrane Technique as an Innovative Minimally Invasive Technique

NCT ID: NCT06134869

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-02-01

Brief Summary

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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

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Conditions

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Bone Graft Keratinized Tissue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients requiring horizontal bone augmentation in the posterior mandible

Group Type OTHER

Bone augmentation

Intervention Type PROCEDURE

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

Interventions

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Bone augmentation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Abdel Rahman Kassir

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinic 506

Beirut, Ashrafieh, Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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USJ-2023-241

Identifier Type: -

Identifier Source: org_study_id

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