Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

Not Applicable

Recruiting

• Conditions: Gingival Recession, Generalized

• Registration Number: NCT05370456
• Lead Sponsor: University of Turin, Italy

Brief Summary

The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-03
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-19
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• At least 18 years old and able to sign informed consent
• At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
• A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
• Available to attend study related procedures (including follow-up visits)

Exclusion Criteria

• Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
• Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
• Pregnant or nursing women;
• History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
• Furcation involvement in the teeth to be included;
• Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
• Presence of fixed or removable prosthesis in the area to be treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Recession Reduction (RecRed)	6 months; 1 year	Mean changes in mm in recession depth between baseline and 1-year

Secondary Outcome Measures

Name	Time	Method
Complete Root Coverage (CRC)	6 months; 1 year	Percentage of sites with complete root coverage after 1-year
Keratinised tissue height (KTH) changes	6 months; 1 year	Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Post-operative morbidity (pain, swelling, discomfort)	14 days	Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire
Mean Root Coverage (MRC)	6 months; 1 year	Percentage of mean root coverage after 1-year

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, Italy