Status:
COMPLETED
Evaluation of the Efficacy of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing
Lead Sponsor:
Sterify S.r.l.
Collaborating Sponsors:
Sciently di Omar Sabry
Conditions:
Parodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure, in terms of periodontal...
Detailed Description
The purpose of the study is to test the safety and efficacy of STERIFY GEL in promoting healing of periodontal pockets following SRP, compared with treatment with SRP alone. With specific visco-elasti...
Eligibility Criteria
Inclusion
- Patients with grade III and IV chronic periodontal disease according to the European Federation of Periodontology classification involving at least two sites
- Adherence to the study and signing of informed consent
- Major age- Participants with a minimum of 6 teeth with periodontal pocket depth greater than 5mm- Participants with at least 20 teeth
Exclusion
- Established hypersensitivity to one or more components of the device- Pregnancy or lactation- Heavy smoker (more than 9 cigarettes per day)- Concomitant dental disease, except periodontitis, or planned treatment that may interfere with the study or study procedure, such as dental surgery or tooth implantation- Diabetes mellitus, rheumatoid arthritis, or other chronic diseases that may affect disease or treatment
- Aggressive periodontitis
- History of radiation or chemotherapy
- Autoimmune mucosal diseases
- Mental illnesses
- Parafunctions such as bruxism
- Use of antibiotics in the past 3 months
- Periodontal surgeries in the past 12 months in the areas covered by the study
Key Trial Info
Start Date :
December 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05975177
Start Date
December 3 2022
End Date
April 6 2023
Last Update
August 7 2023
Active Locations (1)
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1
Odontostomatologia, ASST dei Sette Laghi
Varese, Italy, 21100