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

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

Not Recruiting
18-70 years
All
Phase N/A

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Overview

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).

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

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 details
    Peri-implant Mucositis
    Mucositis Oral

NCT05926557

Federico II University

30 March 2026

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