Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peri-implant Mucositis
- Sponsor
- Federico II University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change of BoP (+/-)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Luca Ramaglia
Clinical Professor
Federico II University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Non-smokers and smokers ( ≤ 10 cigarettes/day);
- •Presence of at least 1 implant in mucositis, clinically and radiographically detected;
- •The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown), cemented or screwed.
Exclusion Criteria
- •Cancer patients;
- •Periodontally Compromised Patients;
- •Uncontrolled diabetic patients;
- •Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
- •Pregnant or breastfeeding patients;
- •Implants that support mobile prosthetic products;
- •Implants in peri-implantitis, detected clinically and radiographically.
Outcomes
Primary Outcomes
Change of BoP (+/-)
Time Frame: baseline, 1 and 3 months after periodontal therapy
Bleeding on periodontal probing
Secondary Outcomes
- Change of Probing Depth (PD; millimeters)(baseline, 1 and 3 months after periodontal therapy)
- Change of Full-mouth Bleeding Score (FMBS; %)(baseline, 1 and 3 months after periodontal therapy)
- Change of Full-mouth Plaque Score (FMPS; %)(baseline, 1 and 3 months after periodontal therapy)