Pontic Site Soft Tissue Augmentation Using De-epithelized Connective Tissue Graft Versus Partially De-epithelized Connective Tissue Graft

Assessment of Soft Tissue Profile After Pontic Site Development Using De-Epithelized Connective Tissue Graft Versus Partially De-Epithelized Connective Tissue Graft: A Randomized Controlled Clinical Trial.

a comparative study to evaluate the pontic site soft tissue augmentation by partially de-epithelized connective tissue graft versus completely de-epithelized connective tissue graft (both grafts harvested from the hard palate). pontic site soft tissue augmentation allows the correction of soft tissue to allow proper fixed dental bridge fabrication (for esthetic and functional purposes)

Study Overview

Study Type

Interventional

Enrollment (Actual)

24

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

      • Giza, Egypt
        • Modern Sciences and Arts 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

Yes

Description

Inclusion Criteria:

  • age 20-45 years
  • medically free
  • bounded missing teeth
  • patient accepting the fixed prosthetics as a treatment option
  • restorable adjacent abutments
  • periodontally healthy adjacent abutments
  • motivated patient to have the treatment
  • bleeding and plaque index less than 20%

Exclusion Criteria:

  • systemic diseases
  • smoking
  • pregnancy
  • patients with pervious soft tissue grafting

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: intervention (using autogenous de-epithelized connective tissue graft for pontic site)
intervention (using autogenous de-epithelized connective tissue graft for pontic site soft tissue augmentation
de-epithelized connective tissue graft for soft tissue augmentation for pontic site development
Other: control group ( partially De-Epithelized connective tissue graft )
control group ( partially autogenous De-Epithelized connective tissue graft )
partially de-epithelized connective tissue graft for soft tissue grafting for pontic site development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
keratinized tissue thickness
Time Frame: time of enrollment, 3 and 6 months postoperative
time of enrollment, 3 and 6 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
soft tissue healing index
Time Frame: 6 months postoperative
6 months postoperative
Pain score
Time Frame: 3 and 7 days postoperative
3 and 7 days postoperative

Collaborators and Investigators

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

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)

December 20, 2024

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9.1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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