Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant Mucosal Thickness Enhancement.

NCT04679922 | Completed

• 1 other identifier: OMPDR-07-19-5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this, randomized clinical trial is to determine the clinical efficacy of fascia lata allograft in terms of peri-implant mucosal augmentation, as compared to autologous sub epithelial connective tissue graft, clinically and histologically in human adults .

Conditions

Implant Tissue Failure

Outcome Measures

Primary Outcomes (1)

• Peri-Implant Mucosal Thickness

  The primary outcome of interest will be to measure changes (in mm) in horizontal PMT on the buccal aspect of the edentulous alveolar ridge from baseline (implant placement and grafting) to (4, 8, 12, and 24 weeks) of post-surgical healing.

  Measure changes in mucosal thickness around dental implant at base line and after 6 months.

Study Arms (2)

Peri Implant mucosal thickness connective tissue graft

ACTIVE COMPARATOR

Procedure: Soft Tissue Enhancement around dental implant

Peri Implant mucosal thickness fascia lata graft

EXPERIMENTAL

Procedure: Soft Tissue Enhancement around dental implant

Interventions

Soft Tissue Enhancement around dental implant PROCEDURE

Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Sixteen sites that were met the subsequent inclusion criteria were eligible to contribute in our study were classified randomly by the sealed envelope technique into two treatment groups, 8 sites in each group. Group I (Control Group): Autogenous SCTGs harvested from the palate +dental implants \*. Group II (Experimental Group): FLA \*\*+dental implants. The allocation was withheld from the surgeon (M.H.) until just before the surgical appointment. The clinical examiner (M.S.) was masked to the treatment group for the extent of the study.Three months after implantation, the sites were located, and the thickness of the mucosa will be evaluated using the customized stent. The operculectomy will be performed following the method of Flatebo et al.,22 collecting biopsy specimens of almost constant quality and evaluating clinical thickness without mucosal distortions

Peri Implant mucosal thickness connective tissue graft; Peri Implant mucosal thickness fascia lata graft

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (\< 2mm bucco- lingual thickness).

You may not qualify if:

• Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.
• Acute infection in the area intended for implant placement.

Sponsors & Collaborators

• Mohamed Hamdy Helal: lead
• Tanta University: collaborator

Study Sites (1)

Faculty of dentistry Tanta University

Tanta, 31773, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Malak Yousef Mohamed Shoukheba

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 22, 2020
• Study Start: December 10, 2019
• Primary Completion: July 20, 2020
• Study Completion: November 18, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)