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

Not Applicable

Recruiting

• Conditions: Mucositis Oral; Peri-implant Mucositis
• Interventions: Procedure: Spermidine gel; Procedure: NSMD

• Registration Number: NCT05926557
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study Start: 2023-07-01
• Study First Posted: 2023-07-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spermidine Group	Spermidine gel	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.
NSMD Group	NSMD	Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.

Primary Outcome Measures

Name	Time	Method
Change of BoP (+/-)	baseline, 1 and 3 months after periodontal therapy	Bleeding on periodontal probing

Secondary Outcome Measures

Name	Time	Method
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
Change of Full-mouth Bleeding Score (FMBS; %)	baseline, 1 and 3 months after periodontal therapy	Percentage of all sites exhibiting bleeding
Change of Full-mouth Plaque Score (FMPS; %)	baseline, 1 and 3 months after periodontal therapy	Percentage of all sites exhibiting plaque

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy