NCT05693753

Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
PROCEDURE	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.

Timeline

• Start date: 2023-02-02
• Primary completion: 2024-06-02
• Completion: 2024-12-02
• First posted: 2023-01-23
• Last updated: 2023-06-28

Locations

1 site across 1 country: Italy