Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

NCT05370456 | Unknown

• 1 other identifier: XCM+HA_Turin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession, Generalized

Outcome Measures

Primary Outcomes (1)

• Mean Recession Reduction (RecRed)

  Mean changes in mm in recession depth between baseline and 1-year

  6 months; 1 year

Secondary Outcomes (4)

• Complete Root Coverage (CRC)

  6 months; 1 year

• Mean Root Coverage (MRC)

  6 months; 1 year

• Keratinised tissue height (KTH) changes

  6 months; 1 year

• Post-operative morbidity (pain, swelling, discomfort)

  14 days

Study Arms (2)

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

EXPERIMENTAL

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

Xenogenic collagen matrix (XCM)

ACTIVE COMPARATOR

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

Procedure: Treatment of MAGRs with mCAF technique and XCM

Interventions

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

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.

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

Treatment of MAGRs with mCAF technique and XCM PROCEDURE

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.

Xenogenic collagen matrix (XCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Mario Aimetti, PA

CONTACT

00390116331541; mario.aimetti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: May 3, 2022
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

IT (1)