Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926557
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-06-22
Brief Title:
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None