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

NCT04679922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-12-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Mohamed Hamdy Helal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2020-07-20
Completion
2020-11-18

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679922 on ClinicalTrials.gov