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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel

Conditions
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Peri-implant Mucositis, Mucositis Oral

Intervention / Treatment
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* Procedure: Spermidine gel
* Procedure: NSMD


Participation Criteria
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Eligibility Criteria
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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, 3-element bridge), cemented or screwed. Exclusion Criteria: Cancer 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 and after 3 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spermidine Group<br>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. | Procedure: Spermidine gel<br>* First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel<br>|
| Active Comparator: NSMD Group<br>Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips. | Procedure: NSMD<br>* Only mechanical debridement with curettes and scaler peek tips<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BoP (+/-) | Bleeding on periodontal probing | baseline, 3 months after periodontal therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Full-mouth Plaque Score (FMPS; %) | Percentage of all sites exhibiting plaque | baseline, 3 months after periodontal therapy | 
| Change of Full-mouth Bleeding Score (FMBS; %) | Percentage of all sites exhibiting bleeding | baseline, 3 months after periodontal therapy | 
| Change of Probing Depth (PD; millimeters) | Distance from the gingival margin to the bottom of the peri-implant pocket | baseline, 3 months after periodontal therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implant Mucositis, Spermidine