ClinicalTrials.Veeva

Menu

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

M

Mohamed Hamdy Helal

Status

Completed

Conditions

Implant Tissue Failure

Treatments

Procedure: Soft Tissue Enhancement around dental implant

Study type

Interventional

Funder types

Other

Identifiers

NCT04679922
OMPDR-07-19-5

Details and patient eligibility

About

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 .

Full 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.

Enrollment

20 patients

Sex

All

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups

Peri Implant mucosal thickness connective tissue graft
Active Comparator group
Treatment:
Procedure: Soft Tissue Enhancement around dental implant
Peri Implant mucosal thickness fascia lata graft
Experimental group
Treatment:
Procedure: Soft Tissue Enhancement around dental implant

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems