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

NCT05926557 | Recruiting DMC

• 1 other identifier: 249/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Peri-implant Mucositis; Mucositis Oral

Keywords

Peri-implant Mucositis; Spermidine

Outcome Measures

Primary Outcomes (1)

• Change of BoP (+/-)

  Bleeding on periodontal probing

  baseline, 1 and 3 months after periodontal therapy

Secondary Outcomes (3)

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

  baseline, 1 and 3 months after periodontal therapy

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

  baseline, 1 and 3 months after periodontal therapy

• Change of Probing Depth (PD; millimeters)

  baseline, 1 and 3 months after periodontal therapy

Study Arms (2)

Spermidine Group

EXPERIMENTAL

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

NSMD Group

ACTIVE COMPARATOR

Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.

Procedure: NSMD

Interventions

Spermidine gel PROCEDURE

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

Spermidine Group

NSMD PROCEDURE

Only mechanical debridement with curettes and scaler peek tips

NSMD Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Luca Ramaglia

CONTACT

+393476912911; luca.ramaglia@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients are not masked with respect to test and control procedures, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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, 1 and 3 months.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)