Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant

January 27, 2026 updated by: Ahmed Abo El Futtouh, Misr International University

Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial

Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement & simultaneous FGG or the conventional FGG protocol prior to implant placement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11347
        • Recruiting
        • International Dental Continuing Education
        • Contact:
          • Ahmed Abou El Fetthouh, PhD

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

Yes

Description

Inclusion Criteria:

  • Adults at or above the age of 18.
  • Lower Posterior missing tooth/ teeth with minimal KT < 2mm

  • Sufficient alveolar ridge length minimum 13-15 mm to IAN

    •. Sufficient alveolar ridge width minimum of 6 mm

  • Patients able to tolerate surgical periodontal procedures.
  • Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion Criteria

  • Patients diagnosed with periodontal diseases (Caton et al., 2018).
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
  • Patients with active infection related to the site of implant.
  • Patients with parafunctional habits.
  • Patients with shallow vestibule

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: One Step Protocol
FGG simultaneous with delayed implant placement
Procedure: One Step Protocol
FGG will be done simultaneous with implant placement
Active Comparator: Two Steps protocol
Conventional FGG protocol, prior to implant placement
Procedure: Two Steps Protocol
Conventional FGG protocol, prior to implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue width
Time Frame: 0 - 3 - 6 - 12 months
Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative
0 - 3 - 6 - 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival Rate
Time Frame: 12 Months
12 Months
Linear changes in buccal soft tissue contour
Time Frame: 0-3, 0-6, 0-12 Months
0-3, 0-6, 0-12 Months
Interdental Papilla height changes
Time Frame: 12 months
12 months
Midfacial margin changes
Time Frame: 12 Months
12 Months
Crestal bone level changes
Time Frame: 12 Months
12 Months
Bone labial to the implant
Time Frame: 12 Months
12 Months

Collaborators and Investigators

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

Sponsor

Misr International University

Collaborators

International Dental Contiuing Education

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 (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IDCE - 13

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

product manufactured in and exported from the U.S.

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 Free Gingival Graft

Clinical Trials on One Step Protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe