Back to resultsTreatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
Primary Purpose
Peri-implant Mucositis, Mucositis Oral
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Spermidine gel
NSMD
Sponsored by
About this trial
This is an interventional treatment trial for Peri-implant Mucositis focused on measuring Peri-implant Mucositis, Spermidine
Eligibility Criteria
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.
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spermidine Group
NSMD Group
Arm Description
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.
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.
Outcomes
Primary Outcome Measures
Change of BoP (+/-)
Bleeding on periodontal probing
Secondary Outcome Measures
Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Change of Probing Depth (PD; millimeters)
Distance from the gingival margin to the bottom of the peri-implant pocket
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05926557
Brief Title
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
Official Title
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis, Mucositis Oral
Keywords
Peri-implant Mucositis, Spermidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spermidine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
NSMD Group
Arm Type
Active Comparator
Arm Description
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.
Intervention Type
Procedure
Intervention Name(s)
Spermidine gel
Intervention Description
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
Intervention Type
Procedure
Intervention Name(s)
NSMD
Intervention Description
Only mechanical debridement with curettes and scaler peek tips
Primary Outcome Measure Information:
Title
Change of BoP (+/-)
Description
Bleeding on periodontal probing
Time Frame
baseline, 3 months after periodontal therapy
Secondary Outcome Measure Information:
Title
Change of Full-mouth Plaque Score (FMPS; %)
Description
Percentage of all sites exhibiting plaque
Time Frame
baseline, 3 months after periodontal therapy
Title
Change of Full-mouth Bleeding Score (FMBS; %)
Description
Percentage of all sites exhibiting bleeding
Time Frame
baseline, 3 months after periodontal therapy
Title
Change of Probing Depth (PD; millimeters)
Description
Distance from the gingival margin to the bottom of the peri-implant pocket
Time Frame
baseline, 3 months after periodontal therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
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