Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
NCT ID: NCT05926557
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-07-01
2024-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Spermidine Group
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.
Spermidine gel
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
NSMD Group
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.
NSMD
Only mechanical debridement with curettes and scaler peek tips
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Federico II University
OTHER
Responsible Party
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Luca Ramaglia
Clinical Professor
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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249/2023
Identifier Type: -
Identifier Source: org_study_id
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