Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel

Federico II University

Status: Enrolling

Conditions: Mucositis Oral; Peri-implant Mucositis

Treatments: Procedure: Spermidine gel; Procedure: NSMD

Study type: Interventional

Funder types: Other

Identifiers

NCT05926557

249/2023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Spermidine Group

Experimental group

Description:

Mechanical therapy (NSMD) will be performed 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.

Treatment:

Procedure: Spermidine gel

NSMD Group

Active Comparator group

Description:

Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.

Treatment:

Procedure: NSMD