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Completed

NCT Number: NCT03862534

CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL

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).

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

CAF

Procedure

After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession

CAF + CTG

Procedure

After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession

Primary outcomes

  1. Recession Reduction

    Time frame: At 12 months

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

  2. Complete Root Coverage (CRC)

    Time frame: At 12 months

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

Secondary outcomes

  1. Root coverage Esthetic Score (RES)

    Time frame: At 12 months

    Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)

  2. Gingival Thickness (GT)

    Time frame: Baseline - 12 months

    Gingival thickness in mm, measured with an endodontic file and a digital caliper.

  3. Keratinized Tissue (KT)

    Time frame: Baseline - 6 and 12 months

    Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe

  4. KTgain

    Time frame: At 12 months

    Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline

  5. Gingival Recesión (REC)

    Time frame: Baseline - 6 and 12 months

    The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe

  6. Root sensitivity

    Time frame: Baseline - 6 and 12 months

    Toot sensitivity reported by the patient present or absent

  7. SensVAS

    Time frame: Baseline - 6 and 12 months

    Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

  8. SurTime

    Time frame: At surgery

    Surgical Time in minutes from the end of anesthesia to the sutures

  9. Anti-infammTab

    Time frame: 1 week post-surgery

    Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.

  10. DiscVAS

    Time frame: 1 week post-surgery

    Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

  11. AesthVAS

    Time frame: At 12 months

    Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • University of Roma La Sapienza

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2019
Registry last updated
Mar 27, 2025

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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