Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

University of Turin

Status: Enrolling

Conditions: Gingival Recession, Generalized

Treatments: Procedure: Treatment of MAGRs with mCAF technique and XCM; Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM

Study type: Interventional

Funder types: Other

Identifiers

NCT05370456

XCM+HA_Turin

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA)

Experimental group

Description:

Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel

Treatment:

Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM

Xenogenic collagen matrix (XCM)

Active Comparator group

Description:

Multiple coronally advanced flap technique (mCAF) with the use of a XCM

Treatment:

Procedure: Treatment of MAGRs with mCAF technique and XCM