MCAF and EMD With and Without CTG Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial

Modified Coronally Advanced Flap and Enamel Matrix Derivative With and Without Connective Tissue Graft Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial

Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Connective tissue graft wall technique

Detailed Description

Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession. The objectives is to assess the probing pocket depth reduction, clinical attachment level gain, patient esthetic evaluation, complete root coverage and mean root coverage. the control group will be treated with modified coronally advanced flap with connective tissue graft and enamel matrix derivative and the study group will be treated with modified coronally advanced flap with connective tissue graft wall and enamel matrix derivative. The total number of participants included will be 24 (Control-12; Study-12) with a 6 month follow up.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prabhuji MLV, MDS; Phone Number: 9448057407; Email: prabhujimlv@gmail.com

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 562157
      • Recruiting
      • Dr. Prabhuji MLV
      • Contact: dr. prabhuji mlv, mds; Phone Number: 9448057407; Email: prabhujimlv@gmail.com
      • Contact: Dr. Vinodini A, MDS; Phone Number: 9791810495; Email: drvinosasi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants aged 18-60 years
• Systemically healthy individuals
• Participants with Miller's Class III and IV or Cairo's RT3 gingival recession in maxillary and mandibular anteriors.
• Participants with Nordland and Tarnow's papillary recession of either I, II or III.
• Presence of interdental PPD, CAL and recession
• Radiographic evidence of interdental bone loss
• No prior experience of root coverage procedures
• Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS < 25% and FMBS < 25%).

Exclusion Criteria:

• Grade III mobile teeth
• Pathologically migrated teeth
• Endodontically treated teeth
• Open contacts
• Pregnancy and lactating women
• Participants with systemic conditions
• Untreated periodontitis
• Persistence of uncorrected gingival trauma from tooth brushing
• Self-reported current smoking
• Presence of medical contraindications to elective surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Connective tissue graft wall technique	Procedure: Connective tissue graft wall technique; Harvested connective tissue graft will be placed over the exposed root surface like a wall to cover the gingival recession; Other Names: Connective tissue graft technique
Active Comparator: Control group; Connective tissue graft	Procedure: Connective tissue graft wall technique; Harvested connective tissue graft will be placed over the exposed root surface like a wall to cover the gingival recession; Other Names: Connective tissue graft technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root coverage	Mean root coverage Cairo's RT3 gingival recession treated with MCAF + CTG wall + EMD technique is non-inferior to MCAF + CTG + EMD in terms of root coverage.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival health and evaluation	clinical attachment level	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 19, 2024
• Primary Completion (Estimated): January 12, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 02_D012_147464

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No