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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295653
• Other study ID #: 7-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: ahmed a abdelsayed
• Phone: +201090609989
• Email: ahmedaboelnagah[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculity of Dentistry Tanta University	Tanta	Elgarbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mid-buccal keratinized mucosal width	measure change (in mm) in mid-buccal keratinized mucosal width in an apico-coronal direction	six month