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

February 26, 2024 updated by: Luca Ramaglia, Federico II University

Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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