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Completed

NCT Number: NCT05783258

Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage

The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.

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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

Michele Paolantonio

Pescara, 65121, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of a class RT1 recession;
  • age > 18 years;
  • systemic health conditions that do not affect the periodontium;
  • Non smoker;
  • FMPS and FMBS values < 20% before the surgical procedure;
  • absence of implants or subgingival restorations in the sites to be treated;
  • presence of adequate tissue distal to the last maxillary molar.

Treatment and study plan

Periodontal surgery with CAF+tSCTG

Procedure

Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.

Periodontal surgery with CAF+L-PRF

Procedure

Coronally advanced flap and L-PRF membranes

Primary outcomes

  1. Gingival thickness

    Time frame: 12 months

    Gingival tissue thickness 2 mm apical to the recession

Secondary outcomes

  1. Keratinized tissue height

    Time frame: 12 months

    Distance between gingival margin and Mucogingival Junction

  2. Gingival recession

    Time frame: 12 months

    Distance from cementoenamel junction and gingival margin

  3. Complete root coverage

    Time frame: 12 months

    Percentage of experimental sites that achieved complete root surface coverage.

  4. Clinical attachment level

    Time frame: 12 months

    Distance between cementoenamel junction(CEJ) and depth of the pocket

  5. Pocket depth

    Time frame: 12 months

    Distance between gingival margin and bottom of the pocket

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Nov 21, 2023

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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