Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

Gingival Recession, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693753
• Other study ID #: XCMTurin
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: December 2, 2024

Study information

• Verified date: June 2023
• Source: University of Turin, Italy
• Contact: Mario Aimetti, MD
• Phone: 0116331546
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized

Intervention

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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Recession Reduction (RecRed)	Mean changes in mm in recession depth between baseline and 1-year	6 months; 1 year
Secondary	Complete Root Coverage (CRC)	Percentage of sites with complete root coverage after 1-year	6 months; 1 year
Secondary	Mean Root Coverage (MRC)	Percentage of mean root coverage after 1-year	6 months; 1 year
Secondary	Keratinised tissue height (KTH) changes	Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year	6 months; 1 year
Secondary	Post-operative morbidity (pain, swelling, discomfort)	Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire	14 days