Autogenous Soft Tissue Grafts for Primary Closure Over Immediately Placed Dental Implants (BFP - FGG)

April 20, 2026 updated by: Mansoura University

How to Place Autogenous Soft Tissue Grafts Ideally for Primary Closure Over Immediately Placed Dental Implants? A Randomized Clinical Trial

The aim of this interventional study is to evaluate the best method to place the autogenous soft tissue grafts for primary closure over immediately-placed dental implants.

- Primary hypothesis, there is no differences between the two techniques of placement.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The peri-implant mucosa provides protection to the underlying bone via its immune response and protection from apical biofilm migration. An adequate band of attached keratinized mucosa limit early marginal bone loss and improved aesthetic outcomes around implant prostheses. There are several effective socket seal surgery (SSS) techniques to improve the clinical results in the preservation of the alveolar ridge and lessen bone resorption.

Autologous soft tissue grafts still provide the gold standard in gaining keratinized tissue and mucosal thickness compared to autologous substitutes on the market. Simultaneous soft tissue grafts at the time of implant placement can counteract the reduction in ridge width and maintain the ridge architecture regardless of the soft tissue phenotype at the site.

Study Type

Interventional

Enrollment (Estimated)

20

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:

  • Good oral hygiene.
  • Medically free from systemic diseases that actually contraindicate implant surgery.
  • Patient cooperation.
  • The presence of the intact walls of the socket after tooth extraction.

Exclusion Criteria:

  • General contraindications for dental and/or surgical treatments.
  • Concurrent or previous radiotherapy of head area.
  • Smoking.
  • Pregnancy.
  • Patients refused the procedure.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Free autogenous soft tissue graft that will be placed without split thickness flaps
Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed without split thickness flaps.
Procedure: Free autogenous soft tissue grafts
Free autogenous soft tissue grafts (Buccal Pad Fat and Palatal Gingival Graft) that will be placed over immediately-placed dental implants
Other: Free autogenous soft tissue graft that will be placed within the prepared split thickness flaps
Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed within the prepared split thickness flaps
Procedure: Free autogenous soft tissue grafts
Free autogenous soft tissue grafts (Buccal Pad Fat and Palatal Gingival Graft) that will be placed over immediately-placed dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone Loss
Time Frame: 6 months postoperative
Marginal Bone Loss around immediately-placed dental implants will be measured in millimeters on cross-sectional view of CBCT
6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft Tissue Healing
Time Frame: At insertion of the prosthetic part (T0) After 2-month post-insertion of the prosthetic part
Using Pink Esthetic Score
At insertion of the prosthetic part (T0) After 2-month post-insertion of the prosthetic part

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)

November 1, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RP.25.05.3

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.

Clinical Trials on Soft Tissue Augmentation at Dental Implants

Clinical Trials on Free autogenous soft tissue grafts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe