The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach

NCT06272006 | Completed

• 1 other identifier: Anatomical recession
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are: Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments? The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Anatomical Recession Rate (ARR)

  The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage.

  12 months post-treatment

Secondary Outcomes (7)

• Clinical Attachment Level (CAL)

  Baseline, 3, 6, and 12 months post-treatment

• Gingival Thickness (GT)

  Baseline and 12 months post-treatment

• Keratinized Tissue Thickness (KTT)

  Baseline, 3, 6, and 12 months post-treatment

• Wound healing index (WHI)

  2 weeks post-treatment

• Tissue appearance

  6 and 12 months post-treatment

Study Arms (2)

Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG)

EXPERIMENTAL

Participants in this arm will receive a Coronally Positioned Flap (CPF) surgery combined with a Connective Tissue Graft (CTG). The CPF technique involves surgically repositioning the gum tissue to cover exposed root surfaces, while the CTG procedure involves transplanting connective tissue to the area of gingival recession to encourage regeneration and coverage of exposed roots. This arm aims to evaluate the effectiveness of CPF with CTG in improving gingival recession and periodontal health.

Procedure: Coronally Positioned Flap with Connective Tissue Graft

Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG)

EXPERIMENTAL

This arm involves participants receiving the Modified Coronally Advanced Tunnel (MCAT) procedure along with a Connective Tissue Graft (CTG). The MCAT technique is a less invasive approach that creates a tunnel under the gum through which the connective tissue graft is placed without making significant incisions. This method aims to treat gingival recession by encouraging gum regeneration over the exposed roots, with the goal of improving periodontal outcomes and reducing recession.

Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft

Interventions

Coronally Positioned Flap with Connective Tissue Graft PROCEDURE

his intervention involves surgically repositioning the gum tissue over the exposed tooth root and adding a connective tissue graft. The graft is obtained from the patient's palate and placed in the area of gingival recession to promote tissue regeneration and enhance root coverage. The procedure aims to reduce gingival recession and improve periodontal health.

Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG)

Modified Coronally Advanced Tunnel with Connective Tissue Graft PROCEDURE

This intervention utilizes a minimally invasive technique to create a tunnel beneath the gum tissue, through which a connective tissue graft is placed. The graft, sourced from the patient's palate, is used to encourage the growth of new gum tissue over the exposed root. This method is designed to minimize trauma and promote faster recovery, aiming to improve root coverage and periodontal outcomes.

Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18 to 60 years.
• Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
• Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
• Ability to provide informed consent for participation in the study.

You may not qualify if:

• Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
• Current smokers or those who have quit smoking less than 6 months before the study.
• Women who are pregnant or breastfeeding.
• Participants who have received periodontal or gingival recession treatment in the study area within the last year.
• Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Gencay Keceli, PHD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study implements single-blind masking where outcomes assessors are unaware of participants' group assignments to minimize bias. While blinding participants and care providers is not feasible due to the nature of surgical interventions, strict protocols ensure assessors remain blinded to treatment allocation throughout the study, enhancing outcome evaluation objectivity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up.

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 22, 2024
• Study Start: February 24, 2024
• Primary Completion: February 4, 2025
• Study Completion: March 5, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

TU (1)