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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926557
• Other study ID #: 249/2023
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Luca Ramaglia
• Phone: +393476912911
• Email: luca.ramaglia[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

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, 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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Peri-implant Mucositis
• Stomatitis

Intervention

Procedure:
• Spermidine gel
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
• NSMD
Only mechanical debridement with curettes and scaler peek tips

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of BoP (+/-)	Bleeding on periodontal probing	baseline, 3 months after periodontal therapy
Secondary	Change of Full-mouth Plaque Score (FMPS; %)	Percentage of all sites exhibiting plaque	baseline, 3 months after periodontal therapy
Secondary	Change of Full-mouth Bleeding Score (FMBS; %)	Percentage of all sites exhibiting bleeding	baseline, 3 months after periodontal therapy
Secondary	Change of Probing Depth (PD; millimeters)	Distance from the gingival margin to the bottom of the peri-implant pocket	baseline, 3 months after periodontal therapy