Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement

Tanta University1 site in 1 country26 target enrollmentMarch 1, 2024

ConditionsDental Implant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Implant
Sponsor: Tanta University
Enrollment: 26
Locations: 1
Primary Endpoint: measure changes in periimplant mucosal thickness
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

April 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tanta University

Responsible Party

Principal Investigator

Mohamed Hamdy Helal

Lecturer of Oral Medicine, Periodontology, Oral Diagnosis & Radiology

Tanta University

Eligibility Criteria

Inclusion Criteria

•Patients with good systemic health with no contraindication for periodontal surgery.
•No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
•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

•Medically compromised patients and systemic conditions precluding periodontal surgery.
•Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
•Patients subjected to irradiation in the head and neck area.
•Patients treated or under treatment with intravenous amino bisphosphonates.
•Patient affected by active periodontitis or has poor oral hygiene and motivation.
•Uncontrolled diabetes mellitus.
•Pregnant women or planning become pregnant, and nursing mothers.

Outcomes

Primary Outcomes

measure changes in periimplant mucosal thickness

Time Frame: six months

The primary outcome of interest will be to measure changes (in mm) in horizontal periimplant mucosal thicknesson the buccal aspect of the edentulous alveolar ridge from baseline (BL) (implant placement and grafting) to (3 and 6 month) of post-surgical healing.