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Clinical Trials/NCT03862534
NCT03862534
Completed
Not Applicable

Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial

University of Florence0 sites30 target enrollmentOctober 2014
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ConditionsGingival Recession

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
University of Florence
Enrollment
30
Primary Endpoint
Recession Reduction
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Francesco Cairo

Head, Research Unit in Periodontology and Periodontal Medicine

University of Florence

Eligibility Criteria

Inclusion Criteria

  • •Age ≥18 years
  • •No systemic diseases or pregnancy.
  • •Self-reported smoking ≤ 10 cigarettes/day.
  • •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).
  • •Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.
  • •Presence of NCCL associated with recession
  • •No history of mucogingival or periodontal surgery at experimental sites.

Exclusion Criteria

  • •Prosthetic crown at experimental teeth.
  • •Gingival recessions presenting minimal amount (\< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.

Outcomes

Primary Outcomes

Recession Reduction

Time Frame: At 12 months

Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.

Complete Root Coverage (CRC)

Time Frame: At 12 months

Absence or presence of gingival recession at 12 months follow-up.

Secondary Outcomes

  • Keratinized Tissue (KT)(Baseline - 6 and 12 months)
  • SensVAS(Baseline - 6 and 12 months)
  • Gingival Recesión (REC)(Baseline - 6 and 12 months)
  • Anti-infammTab(1 week post-surgery)
  • AesthVAS(At 12 months)
  • Gingival Thickness (GT)(Baseline - 12 months)
  • KTgain(At 12 months)
  • Root sensitivity(Baseline - 6 and 12 months)
  • Root coverage Esthetic Score (RES)(At 12 months)
  • SurTime(At surgery)
  • DiscVAS(1 week post-surgery)

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