NCT06134869

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

August 10, 2023

Last Update Submit

November 15, 2023

Conditions

Bone GraftKeratinized Tissue

Outcome Measures

Primary Outcomes (1)

  • Hard tissue gain

    Bone thickness measured clinically and on CBCT (during bone grafting and at re-entry)

    5 months

Secondary Outcomes (1)

  • Soft tissue gain

    5 months

Study Arms (1)

Patients requiring horizontal bone augmentation in the posterior mandible

OTHER
Procedure: Bone augmentation

Interventions

Bone augmentationPROCEDURE

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults
  • Free of any systemic disease affecting bone metabolism
  • Highly compliant
  • Good oral hygiene

You may not qualify if:

  • Untreated periodontal disease
  • Heavy smokers
  • Excessive alcohol consumption
  • Uncontrolled systemic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic 506

Beirut, Ashrafieh, Lebanon

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 10, 2023

First Posted

November 18, 2023

Study Start

January 1, 2019

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data are available at any time

Locations

LE(1)