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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05693753
Other study ID # XCMTurin
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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