Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingival Recession, Generalized
- Sponsor
- University of Turin, Italy
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mean Recession Reduction (RecRed)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Mean Recession Reduction (RecRed)
Time Frame: 6 months; 1 year
Mean changes in mm in recession depth between baseline and 1-year
Secondary Outcomes
- Mean Root Coverage (MRC)(6 months; 1 year)
- Post-operative morbidity (pain, swelling, discomfort)(14 days)
- Keratinised tissue height (KTH) changes(6 months; 1 year)
- Complete Root Coverage (CRC)(6 months; 1 year)