The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement).
Following the recording of the clinical parameters (BoP, FMPS, FMBS, PD), mechanical therapy (NSMD) will be performed in the Test group (spermidine gel) by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Control group will instead be treated only through the NSMD. Finally, after 3 months the clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again and the final evaluation will be performed. Data analysis will be performed using statistical software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
Only mechanical debridement with curettes and scaler peek tips
University of Naples Federico II
Naples, Italy, Italy
Change of BoP (+/-)
Bleeding on periodontal probing
Time frame: baseline, 1 and 3 months after periodontal therapy
Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Time frame: baseline, 1 and 3 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Time frame: baseline, 1 and 3 months after periodontal therapy
Change of Probing Depth (PD; millimeters)
Distance from the gingival margin to the bottom of the peri-implant pocket
Time frame: baseline, 1 and 3 months after periodontal therapy
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