Fascia Lata Allograft Versus Subepithelial Connective Tissue Grafts in the Peri-Implant Mucosal Thickness Enhancement.
- Conditions
- Implant Tissue Failure
- Interventions
- Procedure: Soft Tissue Enhancement around dental implant
- Registration Number
- NCT04679922
- Lead Sponsor
- Mohamed Hamdy Helal
- 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 .
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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).
Uncontrolled diabetes mellitus. Females who were pregnant, or attempting to become pregnant, and nursing mothers.
Acute infection in the area intended for implant placement.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peri Implant mucosal thickness fascia lata graft Soft Tissue Enhancement around dental implant - Peri Implant mucosal thickness connective tissue graft Soft Tissue Enhancement around dental implant -
- Primary Outcome Measures
Name Time Method Peri-Implant Mucosal Thickness Measure changes in mucosal thickness around dental implant at base line and after 6 months. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of dentistry Tanta University
🇪🇬Tanta, Egypt