Open Membrane Technique as an Innovative Minimally Invasi... | NCT06134869

Studies
Open Membrane Technique as an Innovative Minimally Invasive Technique

NCT06134869

Sponsor

Saint-Joseph University

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Bone Graft
Keratinized Tissue

Interventions

Bone augmentation

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Feb 1, 2023Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Aug 10, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients requiring horizontal bone augmentation in the posterior mandible	Other		Procedure: Bone augmentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone augmentation	Procedure	Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap	Patients requiring horizontal bone augmentation in the posterior mandible

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Clinic 506		Beirut	Ashrafieh		Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Any data will be shared with other researches if it is required or will help conducting further studies.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

The data are available at any time

Access Criteria

Not provided

URL

Not provided