Mucositis Oral, Peri-implant Mucositis
Conditions
Keywords
Peri-implant Mucositis, Spermidine
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.
Interventions
PROCEDURESpermidine gel
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
PROCEDURENSMD
Only mechanical debridement with curettes and scaler peek tips
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
All patients are not masked with respect to test and control procedures, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Intervention model description
The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with spermidine gel + non-surgical debridement (NSMD) in Test group and with NSMD alone in Control group. All clinical parameters will be recorded at baseline, 1 and 3 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of BoP (+/-) | baseline, 1 and 3 months after periodontal therapy | Bleeding on periodontal probing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Full-mouth Plaque Score (FMPS; %) | baseline, 1 and 3 months after periodontal therapy | Percentage of all sites exhibiting plaque |
| Change of Full-mouth Bleeding Score (FMBS; %) | baseline, 1 and 3 months after periodontal therapy | Percentage of all sites exhibiting bleeding |
| Change of Probing Depth (PD; millimeters) | baseline, 1 and 3 months after periodontal therapy | Distance from the gingival margin to the bottom of the peri-implant pocket |
Countries
Italy
Outcome results
None listed