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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.
University of Turin
Turin, Italy
RECRUITINGMean Recession Reduction (RecRed)
Mean changes in mm in recession depth between baseline and 1-year
Time frame: 6 months; 1 year
Complete Root Coverage (CRC)
Percentage of sites with complete root coverage after 1-year
Time frame: 6 months; 1 year
Mean Root Coverage (MRC)
Percentage of mean root coverage after 1-year
Time frame: 6 months; 1 year
Keratinised tissue height (KTH) changes
Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year
Time frame: 6 months; 1 year
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
Time frame: 14 days
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