Comparing Tunnel Technique and CAF With CTG in Mandibular Gingival Recession Treatment

March 7, 2024 updated by: Gonzalo Blasi, Universitat Internacional de Catalunya

Tunnel Technique Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Mandibular Gingival Recessions: A Randomized Clinical Trial

The goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. This study, focusing on healthy patients with RT1 and RT2 gingival recessions, aims to determine which surgical approach offers better root coverage for mandibular recession defects. Additionally, it seeks to understand the effects of these techniques on aspects such as keratinized tissue gain, vestibular depth, gingival thickness, and patient-reported outcomes. Participants in this trial will undergo one of the two surgical procedures and are expected to attend a total of six assessment visits. Researchers will compare the results from both groups, those treated with CAF and those with TT+CTG, to discern if one method is superior in achieving more effective root coverage, enhanced aesthetic appearance, and reduced discomfort associated with gingival recession.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is designed to rigorously assess the effectiveness of two surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in the treatment of mandibular gingival recession, specifically targeting RT1 and RT2 types of recessions. The primary objective of this study is to determine which of these approaches provides superior root coverage in managing mandibular recession defects. The secondary objectives include evaluating the impact of these treatments on keratinized tissue gain, changes in vestibular depth, variations in gingival thickness, and patient-reported outcomes such as pain and aesthetic satisfaction.

Healthy participants diagnosed with mandibular gingival recession will be enrolled and randomly assigned to undergo either the CAF or TT+CTG surgical procedure. The study will follow a structured timeline with a total of six assessment visits for each participant, scheduled at key intervals: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation. These time points are chosen to effectively monitor both the immediate and the long-term results of the treatments.

The primary outcome measure, Mean Root Coverage (MRC), will be evaluated at each follow-up visit to quantify the extent of root coverage achieved by the respective surgical techniques. Secondary outcome measures include the assessment of Vestibular Depth (VD), Complete Root Coverage (CRC), changes in Keratinized Tissue Width (KT), and changes in Gingival Thickness (GT). These measures will provide a comprehensive understanding of the physiological and aesthetic impacts of the surgical interventions.

By comparing the outcomes from both treatment groups, the study aims to provide clear evidence on the effectiveness of CAF versus TT+CTG in treating mandibular gingival recession, guiding future clinical decisions and patient care strategies in periodontology.

Study Type

Interventional

Enrollment (Estimated)

34

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

  • Spain
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Recruiting
        • UIC Barcelona - Clinica Universitaria de Odontologia
        • Contact:
          • UIC Universidad Internacional de Catalunya
          • Phone Number: 935042030
          • Email: clinica@uic.es

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

Yes

Description

Inclusion Criteria:

  • ≥18 years; periodontally and systemically healthy
  • presence of RT1 and RT2 gingival recession defects
  • recession in the mandibular arch
  • recession ≥ 2mm in depth at the buccal aspect
  • full-mouth plaque and bleeding score ≤ 20%
  • no previous periodontal surgery
  • presence of identifiable cemento-enamel junction (CEJ) (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

Exclusion Criteria:

  • smokers ≥10 cigarettes a day
  • contraindications for periodontal surgery
  • medications known to affect the gingiva or interfere with wound healing
  • pregnancy
  • active orthodontic therapy
  • caries or restorations in the area to be treated

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: CAF + CTG
This arm involves patients treated with the Coronally Advanced Flap (CAF) technique, a recognized method for treating gingival recession. As an active comparator, this arm serves to compare the effectiveness and outcomes of CAF against the alternative surgical method used in the study.
Procedure: CAF + CTG
Surgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.
Active Comparator: Tunnel Technique + CTG
Patients in this arm receive the Tunnel Technique (TT) with Connective Tissue Grafts (CTG). Also an established method for gingival recession treatment, this arm acts as an active comparator to assess and compare the effectiveness of TT+CTG against the CAF technique.
Procedure: Tunnel Technique + CTG
Surgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Root Coverage (MRC)
Time Frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
he Mean Root Coverage measures the percentage of exposed tooth root that has been covered by gum tissue after surgery, compared to before the treatment.
At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular depth (VD)
Time Frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Measurement of the depth of the vestibular area (the space between the inside of the lip/cheek and the gum) to assess changes post-surgery.
At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Complete Root Coverage (CRC)
Time Frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Assessment of whether the entire exposed root surface is covered by gum tissue post-treatment.
At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in Keratinized Tissue Width (KT)
Time Frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Measurement of the width of keratinized tissue (gum tissue that is firmly attached to the bone) to note any changes following the surgical procedure.
At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in gingival thickness (GT)
Time Frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Assessment of the thickness of the gum tissue to evaluate changes after surgery.
At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

Collaborators and Investigators

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

Sponsor

Universitat Internacional de Catalunya

Investigators

  • Principal Investigator: Gonzalo Blasi, DDS MS, Uic Barcelona

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)

December 11, 2023

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER-ECL-2023-01

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

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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