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

Implant Tissue Failure Clinical Trial

— Fascia Lata  

Official title:

Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679922
• Other study ID #: OMPDR-07-19-5
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: November 18, 2020

Study information

• Verified date: December 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

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 .

The hypothesis of the study is that a similar gain in peri implant mucosal thicknesses will be obtained in sites treated by either a sub epithelial connective tissue graft or a newly developed fascia lata allograft in clinically and histologically in human.

The objective of this study will be to evaluate the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or human Fascia Lata Allograft placed simultaneously with dental implant placement.

Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Participants will be randomized to the control (simultaneous SCTGs) or test (simultaneous FLA) group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 18, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

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).

Exclusion Criteria:

Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.

Acute infection in the area intended for implant placement.

Related Conditions & MeSH terms

• Implant Tissue Failure

Intervention

Procedure:
• Soft Tissue Enhancement around dental implant
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

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Tanta University	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Hamdy Helal	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.