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Completed

NCT Number: NCT05926557

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

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).

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Key information

Conditions

Peri-implant Mucositis Mouth Diseases Mucositis Oral Stomatitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, Italy, 80131

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spermidine gel

Procedure

First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel

NSMD

Procedure

Only mechanical debridement with curettes and scaler peek tips

Primary outcomes

  1. Change of BoP (+/-)

    Time frame: baseline, 1 and 3 months after periodontal therapy

    Bleeding on periodontal probing

Secondary outcomes

  1. Change of Full-mouth Plaque Score (FMPS; %)

    Time frame: baseline, 1 and 3 months after periodontal therapy

    Percentage of all sites exhibiting plaque

  2. Change of Full-mouth Bleeding Score (FMBS; %)

    Time frame: baseline, 1 and 3 months after periodontal therapy

    Percentage of all sites exhibiting bleeding

  3. Change of Probing Depth (PD; millimeters)

    Time frame: baseline, 1 and 3 months after periodontal therapy

    Distance from the gingival margin to the bottom of the peri-implant pocket

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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