Clinical trial NCT05926557: Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
Official title: Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Mucositis Oral
Keywords: Peri-implant Mucositis
Spermidine
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of BoP (+/-)
timeFrame: baseline, 1 and 3 months after periodontal therapy
Secondary outcomes:
measure: Change of Full-mouth Plaque Score (FMPS; %)
timeFrame: baseline, 1 and 3 months after periodontal therapy
measure: Change of Full-mouth Bleeding Score (FMBS; %)
timeFrame: baseline, 1 and 3 months after periodontal therapy
measure: Change of Probing Depth (PD; millimeters)
timeFrame: baseline, 1 and 3 months after periodontal therapy
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: