Clinical trial NCT05370456: Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap
Official title: The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession, Generalized
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone 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) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.


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

Primary outcomes:
measure: Mean Recession Reduction (RecRed)
timeFrame: 6 months; 1 year
Secondary outcomes:
measure: Complete Root Coverage (CRC)
timeFrame: 6 months; 1 year
measure: Mean Root Coverage (MRC)
timeFrame: 6 months; 1 year
measure: Keratinised tissue height (KTH) changes
timeFrame: 6 months; 1 year
measure: Post-operative morbidity (pain, swelling, discomfort)
timeFrame: 14 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
References: