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

Sponsor
Federico II University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05926557
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spermidine gel
  • Procedure: NSMD
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Primary Purpose:
Treatment
Official Title:
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of BoP (+/-) [baseline, 3 months after periodontal therapy]

    Bleeding on periodontal probing

Secondary Outcome Measures

  1. Change of Full-mouth Plaque Score (FMPS; %) [baseline, 3 months after periodontal therapy]

    Percentage of all sites exhibiting plaque

  2. Change of Full-mouth Bleeding Score (FMBS; %) [baseline, 3 months after periodontal therapy]

    Percentage of all sites exhibiting bleeding

  3. Change of Probing Depth (PD; millimeters) [baseline, 3 months after periodontal therapy]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples Federico II Naples Italy 80131

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luca Ramaglia, Clinical Professor, Federico II University
ClinicalTrials.gov Identifier:
NCT05926557
Other Study ID Numbers:
  • 249/2023
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luca Ramaglia, Clinical Professor, Federico II University
Peri-implant Mucositis
Spermidine
Additional relevant MeSH terms:
Mucositis
Stomatitis

Study Results

No Results Posted as of Jul 5, 2023