Clinical Evaluation Comparing Tunneled Coronally Advanced Flap and Modified Coronally Advanced Tunnel With Connective Tissue Graft for Managing Single Gum Recession

November 25, 2025 updated by: Khaled Hashem Kamal, Cairo University

Clinical Evaluation of Tunneled Coronally Advance Flap (TCAF) Versus Modified Coronally Advanced Tunnel With Connective Tissue Graft in Management of Single Recession Defects (RT2): A Randomized Clinical Trial

The technique under investigation aims to provide effective root coverage while offering the advantage of being less invasive.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Limited RCTs have been found in the literature comparing the root coverage capacity of the tunneled coronally advanced flap versus modified coronally advanced tunnel combined with connective tissue graft in single RT2 defects. So, this trial aims to fill this gap of knowledge.

Study Type

Interventional

Enrollment (Estimated)

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 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with single RT2 gingival recession defect ≥ 2 mm
  • Age >18 years old.
  • Systemically healthy patients with no contraindications for periodontal surgeries.
  • Gingival and plaque index less than 20%.
  • No previous surgeries at the defect site.
  • Accepts 6 months follow-up period (compliant patients).

Exclusion Criteria:

  • RT1 gingival recession.
  • Smokers >10 cigarettes a day a contraindicating for any plastic periodontal surgery.
  • Poor oral hygiene.
  • Active periodontitis patients.
  • Patients on medications causing gingival enlargement.
  • Pregnancy.
  • Teeth mobility ≥ 1 mm.
  • Patients using fixed or removable orthodontic appliances.
  • Restoration and/or periapical radiolucency at the defect site.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modified Coronally Advanced Tunnel with Connective Tissue Graft
Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft
Modified coronally advanced tunnel with connective tissue graft without vertical releasing incisions
Experimental: Tunneled Coronally Advance Flap (TCAF) with Connective Tissue Graft
Procedure: Tunneled Coronally Advance Flap with Connective Tissue Graft
Tunneled coronally advance flap with connective tissue graft with one vertical releasing incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Recession Depth (GRD)
Time Frame: 6 months
Measuring gingival recession depth (GRD) using UNC Periodontal probe in millimeter (mm)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Mean Root Coverage (MRC %)
Time Frame: 6 months
Measuring the percentage of mean root coverage (MRC %) using UNC Periodontal Probe in percentage (%)
6 months
Complete Root Coverage (CRC)
Time Frame: 6 months
Measuring the complete root coverage (CRC) visually (Yes/No)
6 months
The Distance between the contact point and the top of the papilla (DCP)
Time Frame: 6 months
Measuring the distance between the contact point and the top of the papilla (DCP) using UNC periodontal probe in millimeter (mm)
6 months
Gingival Recession Width (RW)
Time Frame: 6 months
Measuring the gingival recession width (RW) using UNC periodontal probe in Millimeter (mm)
6 months
Probing Pocket Depth (PPD)
Time Frame: 6 months
Measuring the probing pocket depth (PPD) using UNC periodontal probe in Millimeter (mm)
6 months
Clinical Attachment Level (CAL)
Time Frame: 6 months
Measuring the clinical attachment level (CAL) using UNC periodontal probe in Millimeter (mm)
6 months
Keratinized Tissue Width (KTW)
Time Frame: 6 months
Measuring the keratinized tissue width (KTW) using UNC periodontal probe in Millimeter (mm)
6 months
Gingival Thickness (GT)
Time Frame: 6 months
Measuring the gingival thickness (GT) using endodontic file in Millimeter (mm)
6 months
Root Coverage Esthetic Score (RES)
Time Frame: 6 months
Measuring the root coverage esthetic score (RES) visually with score (0 "minimum" - 10 "maximum")
6 months
Gingival Index (GI)
Time Frame: 6 months
Measuring the gingival index (GI) using UNC periodontal probe with score (0 "minimum" - 3 "maximum")
6 months
Plaque Index (PI)
Time Frame: 6 months
Measuring the plaque index (PI) using UNC periodontal probe with score (0 "minimum" - 3 "maximum")
6 months
Postoperative Patient Satisfaction (Visual Analogue Scale)
Time Frame: 6 months
Measuring the postoperative patient satisfaction (Visual Analogue Scale) using Patient's questionnaire with score (0 "minimum" -10 "maximum")
6 months

Collaborators and Investigators

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

Sponsor

Cairo 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.

Helpful Links

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 (Estimated)

December 14, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Estimated)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU PhD protocol for Khaled

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Limited RCTs have been found in the literature comparing the root coverage capacity of the tunneled coronally advanced flap versus modified coronally advanced tunnel combined with connective tissue graft in single RT2 defects. So, this trial aims to fill this gap of knowledge.

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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