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

NCT06295653 | Not Yet Recruiting

• 1 other identifier: 7-23
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

dental implant; Subepithelial Connective Tissue Graft; Amniotic Chorion Membrane; for Peri-implant Mucosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mid-buccal keratinized mucosal width

  six month

Study Arms (2)

Autogenous Subepithelial Connective Tissue Graft plus dental implants

ACTIVE COMPARATOR

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

Amniotic Chorion Membrane plus dental implant

ACTIVE COMPARATOR

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

Interventions

implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane PROCEDURE

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.

Also known as: measure mucosal thickness with probe, connective tissue grafting from palate

Amniotic Chorion Membrane plus dental implant; Autogenous Subepithelial Connective Tissue Graft plus dental implants

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculity of Dentistry Tanta University

Tanta, Elgarbia, 6620012, Egypt

Location

Central Study Contacts

ahmed a abdelsayed

CONTACT

+201090609989; ahmedaboelnagah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine, Periodontology, Oral Diagnosis & Radiology

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: at the end of the research When the data are available

Locations

EG (1)