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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed a abdelsayed; Phone Number: +201090609989; Email: ahmedaboelnagah@gmail.com

Study Locations

• Egypt
  • Elgarbia
    • Tanta, Elgarbia, Egypt, 6620012
      • Faculity of Dentistry Tanta University
      • Contact: Faten a Seddiq, Faculty Dean; Phone Number: +20 3335631; Email: dean_dent@unv.tanta.edu.eg
      • Principal Investigator: ahmed a abdelsayed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.
• Smokers.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autogenous Subepithelial Connective Tissue Graft plus dental implants; implant placement and augment Subepithelial Connective Tissue Graft and suture implant site	Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane; assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.; Other Names: measure mucosal thickness with probe; connective tissue grafting from palate
Active Comparator: Amniotic Chorion Membrane plus dental implant; implant placement and augment Amniotic Chorion Membrane and suture implant site	Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane; assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.; Other Names: measure mucosal thickness with probe; connective tissue grafting from palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure changes in periimplant mucosal thickness	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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mid-buccal keratinized mucosal width	measure change (in mm) in mid-buccal keratinized mucosal width in an apico-coronal direction	six month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dental implant; Subepithelial Connective Tissue Graft; Amniotic Chorion Membrane; for Peri-implant Mucosa
• Other Study ID Numbers: 7-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: share the results to determine the difference between the materials used in the research and the possibility of using the best ones
• IPD Sharing Time Frame: at the end of the research When the data are available
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No