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

Not Applicable

Not yet recruiting

• Conditions: Dental Implant
• Interventions: Procedure: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane

• Registration Number: NCT06295653
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autogenous Subepithelial Connective Tissue Graft plus dental implants	implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane	implant placement and augment Subepithelial Connective Tissue Graft and suture implant site
Amniotic Chorion Membrane plus dental implant	implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane	implant placement and augment Amniotic Chorion Membrane and suture implant site

Primary Outcome Measures

Name	Time	Method
measure changes in periimplant mucosal thickness	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.

Secondary Outcome Measures

Name	Time	Method
mid-buccal keratinized mucosal width	six month	measure change (in mm) in mid-buccal keratinized mucosal width in an apico-coronal direction

Trial Locations

Locations (1)

Faculity of Dentistry Tanta University; 🇪🇬 Tanta, Elgarbia, Egypt