Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects

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

Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial

The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.

Study Type

Interventional

Enrollment (Estimated)

50

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

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:

  1. Adults above the age of 18 to 50 years.
  2. Males and females as confirmed by asking the female patients about whether they are pregnant or not
  3. Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
  4. Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
  5. Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
  6. Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
  7. Good oral hygiene.
  8. Patient accepts to sign an informed consent.
  9. ASA I or ASA II Patient.

Exclusion Criteria:

  1. Patients with ridge defects due to bone defect
  2. Smoker patients who smoke more than 10 cigarettes per day
  3. Pregnant females

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
Active Comparator: Control group
Will be augmented by the conventional subepithelial connective tissue graft technique.
Procedure: DIPRF
Denuded interpositional pedicled rolled flap technique
Experimental: Experimental group
Augmentation of soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF)
Procedure: DIPRF
Denuded interpositional pedicled rolled flap technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ridge contour thickness gain
Time Frame: 6 months
Ridge contour will be assessed using CBCT analysis using fusion software. The differences between measurement times will indicate the amount of bone gain
6 months

Collaborators and Investigators

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

Sponsor

Misr International University

Investigators

  • Principal Investigator: Hebattallah A Mattar, Misr International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 30, 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

  • FWA #00022887

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.

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