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OpenTrials
Completed

NCT Number: NCT05460182

Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florence

Florence, Tuscany, 50100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAF+CTG

Other

Coronally Advanced Flap + Connective Tissue Graft

CAF

Other

Coronally Advanced Flap

Primary outcomes

  1. Complete Root Coverage (CRC)

    Time frame: After the intervention (10 years)

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

Secondary outcomes

  1. Recession Reduction (RecRed)

    Time frame: After the intervention (10 years)

    Change of the gingival recession, in mm

  2. Root Coverage Aesthetic Score (RES)

    Time frame: After the intervention (10 years)

    A scoring system ranging from 0 to 10

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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