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Clinical Trials/NCT06525285
NCT06525285
Recruiting
Not Applicable

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

Krishnadevaraya College of Dental Sciences & Hospital1 site in 1 country24 target enrollmentJuly 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Enrollment
24
Locations
1
Primary Endpoint
Root coverage
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2024
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Root coverage

Time Frame: 6 months

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.

Secondary Outcomes

  • Gingival health and evaluation(6 months)

Study Sites (1)

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