NCT05926557

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Peri-implant Mucositis
• Mucositis Oral

Interventions

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

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-07-03
• Last updated: 2024-05-24

Locations

1 site across 1 country: Italy