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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2024
CompletedStudy Start
First participant enrolled
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedJuly 29, 2024
July 1, 2024
6 months
July 19, 2024
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Gingival health and evaluation
6 months
Study Arms (2)
Study group
EXPERIMENTALConnective tissue graft wall technique
Control group
ACTIVE COMPARATORConnective tissue graft
Interventions
Harvested connective tissue graft will be placed over the exposed root surface like a wall to cover the gingival recession
Eligibility Criteria
You may qualify if:
- 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%).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Prabhuji MLV
Bengaluru, Karnataka, 562157, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2024
First Posted
July 29, 2024
Study Start
July 19, 2024
Primary Completion
January 12, 2025
Study Completion
April 30, 2025
Last Updated
July 29, 2024
Record last verified: 2024-07