Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Generalized
• Intervention / Treatment: Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM; Procedure: Treatment of MAGRs with mCAF technique and XCM

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Aimetti, PA; Phone Number: 00390116331541; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • University of Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA); Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel	Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM; After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.
ACTIVE_COMPARATOR: Xenogenic collagen matrix (XCM); Multiple coronally advanced flap technique (mCAF) with the use of a XCM	Procedure: Treatment of MAGRs with mCAF technique and XCM; After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Recession Reduction (RecRed)	Mean changes in mm in recession depth between baseline and 1-year	6 months; 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Root Coverage (CRC)	Percentage of sites with complete root coverage after 1-year	6 months; 1 year
Mean Root Coverage (MRC)	Percentage of mean root coverage after 1-year	6 months; 1 year
Keratinised tissue height (KTH) changes	Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year	6 months; 1 year
Post-operative morbidity (pain, swelling, discomfort)	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	14 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2022
• Primary Completion (ANTICIPATED): September 10, 2024
• Study Completion (ANTICIPATED): September 10, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (ACTUAL): May 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: XCM+HA_Turin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No