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Clinical Trials/NCT05460182
NCT05460182
Completed
Not Applicable

Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results

University of Florence1 site in 1 country29 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
University of Florence
Enrollment
29
Locations
1
Primary Endpoint
Complete Root Coverage (CRC)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
March 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Francesco Cairo

Prof.

University of Florence

Eligibility Criteria

Inclusion Criteria

  • Smoking \< 20 cigarettes/day.
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 15% (measured at four sites per tooth).
  • Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession \> 2 mm of depth
  • Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
  • Presence of an identifiable CEJ

Exclusion Criteria

  • Systemic diseases or pregnancy.
  • Systemic antibiotic therapy in the last 6 months.
  • Active periodontal disease with sites showing probing depth \>4 mm.

Outcomes

Primary Outcomes

Complete Root Coverage (CRC)

Time Frame: After the intervention (10 years)

Complete Root Coverage: absence of gingival recession (Yes/No)

Secondary Outcomes

  • Recession Reduction (RecRed)(After the intervention (10 years))
  • Root Coverage Aesthetic Score (RES)(After the intervention (10 years))

Study Sites (1)

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