The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.
The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean \& Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group. Patients will be recruited at Department of Periodontology (Univeristy of Naples "Federico II") and at Department of Periodontology (University of Budapest "Semmelweis"). Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD. All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
Only mechanical debridement with curettes ans scaler tips
Semmelweis University
Budapest, HU, Hungary
University of Naples Federico II
Naples, Italy, Italy
Change of BoP (+/-)
Bleeding on periodontal probing
Time frame: baseline, 6 months after periodontal therapy
Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Time frame: baseline, 6 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Time frame: baseline, 6 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, 6 months after periodontal therapy
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