Fixation of Free Gingival Graft Using Tissue Tacks vs Criss-cross Sutures

September 15, 2026 updated by: October University for Modern Sciences and Arts

Assessment of Pain Score After Fixation of Free Gingival Graft Using Tissue Tacks Versus Criss- Cross Sutures in Cases With Insufficient Keratinized Tissue. A Randomized Controlled Clinical Trial.

Tissue tacks may improve graft stability but their effect on pain is unclear. The study compares tacks and sutures by measuring pain, stability, healing success, and patient comfort.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tissue tacks are a newer method for securing free gingival grafts ,offering potential benefits such as improved graft stability and reduced movement compared to traditional criss- cross sutures. However, the impact of tissue tacks on postoperative pain remains unclear. This study seeks to evaluate whether tissue tacks, while possibly enhancing graft stability and healing, result in higher pain levels compared to sutures, and whether these outcomes affect the overall clinical success and patient comfort during healing.

Study Type

Interventional

Enrollment (Estimated)

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
    • Giza Governorate
      • Giza, Giza Governorate, Egypt
        • Recruiting
        • MSA university
        • Contact:

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 inadequate keratinized tissue requiring free gingival grafts.
  • Age between 18-40 years.
  • Free from systemic diseases that could affect healing.
  • Good oral hygiene.
  • Motivated patients with a willingness to participate and comply with post-operative instructions.

Exclusion Criteria:

  • Medically compromised patients
  • Subjects who underwent radiotherapy or chemotherapy, pregnant women, smokers.

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
Other: criss cross sutures
Fixation of free gingival graft using tissue tacs
Procedure: Criss cross sutures
Fixation of free gingival graft using criss cross sutures
Active Comparator: tissue tacs
Fixation of free gingival graft using tissue tacs
Procedure: Tissue tacs
Fixation of free gingival graft using tissue tacs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score (VAS Score)
Time Frame: 1,3,5,7 days post surgery
Grade from 1-10
1,3,5,7 days post surgery

Collaborators and Investigators

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

Sponsor

October University for Modern Sciences and Arts

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)

January 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • REC-D 6112-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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