Influence of Acellular Dermal Matrix on Peri-implant Soft Tissue Phenotype and Marginal Bone Loss (ADM)

May 1, 2026 updated by: Mansoura University

Influence of Acellular Dermal Matrix on Peri-implant Soft Tissue Phenotype and Marginal Bone Loss Following Immediate Implant Placement in Anterior Maxilla: A Randomized Controlled Clinical Trial

To evaluate soft tissue augmentation using acellular dermal matrix (ADM) over immediately placed dental implants in anterior maxilla.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial was designed to evaluate and compare the efficacy of ADM versus d-PTFE membranes in the preservation of the peri-implant hard and soft tissues in the setting of immediate implant placement on the anterior maxilla.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Faculty of Dentistry - Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with non-restorable maxillary anterior tooth/teeth.
  • Good oral hygiene.
  • Patients' cooperation and fully capable to comply with the study protocol.
  • Age ranges from 18 to 45 years.
  • Free from history of parafunctional habits e.g. clenching and bruxism
  • Sufficient inter- arch space.

Exclusion Criteria:

  • Any local pathological condition that contraindicates implant placement.
  • Pregnancy.
  • Medication that affects bone healing.
  • Psychological problems.
  • Patient had undergone radiation therapy to the head and neck area in the past 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Immediately placed dental implants with high-density polytetrafluorethylene membrane coverage
Procedure: Polytetrafluoroethylene coverage
The socket with immediately placed dental implant was covered with a d-PTFE membrane cut to fit the surgical site
Experimental: Test Group
Immediately placed dental implants with acellular dermal matrix allograft coverage
Procedure: Acellular Dermal Matrix
The socket with immediately placed dental implant was covered with ADM that was inserted into facial and palatal split thickness pouches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant soft-tissue phenotype
Time Frame: Six months following implant placement
A standardized periodontal probe was used to clinically measure the keratinized mucosal width, supracrestal tissue height, and mucosal thickness. They were measured in millimeters (mm)
Six months following implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.26.04.114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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