Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

NCT05693753 | Unknown

• 1 other identifier: XCMTurin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

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)

EXPERIMENTAL

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

Device: Use of XCM for the treatment of MAGRs with mCAF technique

Connective tissue graft (CTG)

ACTIVE COMPARATOR

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

Procedure: Treatment of MAGRs with CTG

Interventions

Use of XCM for the treatment of MAGRs with mCAF technique 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.

Xenogenic collagen matrix (XCM)

Treatment of MAGRs with CTG 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.

Connective tissue graft (CTG)

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)

CIR Dental School

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, MD

CONTACT

0116331546; mario.aimetti@unito.it

Study Design

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

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: February 2, 2023
• Primary Completion: June 2, 2024
• Study Completion: December 2, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

IT (1)