Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

NCT ID: NCT05693753

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2024-12-02

Brief Summary

The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) 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). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.

Conditions

Gingival Recession, Generalized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Xenogenic collagen matrix (XCM)

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

Group Type: EXPERIMENTAL

Use of XCM for the treatment of MAGRs with mCAF technique

Intervention Type: DEVICE

After local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

Connective tissue graft (CTG)

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

Group Type: ACTIVE_COMPARATOR

Treatment of MAGRs with CTG

Intervention Type: PROCEDURE

After local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

Interventions

Use of XCM for the treatment of MAGRs with mCAF technique

After local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

Intervention Type: DEVICE

Treatment of MAGRs with CTG

After local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIR Dental School

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mario Aimetti, MD

Role: CONTACT

mario.aimetti@unito.it

0116331546

Facility Contacts

Mario Aimetti, Prof.

Role: primary

mario.aimetti@unito.it

+39116331541

Other Identifiers

XCMTurin

Identifier Type: -

Identifier Source: org_study_id