Status:
UNKNOWN
Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Sunstar, Inc.
Conditions:
Diabetes
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the clinical and microbiological performance of a probiotic formulation (Sunstar GUM Periobalance) as adjunctive to non-surgical periodontal therapy in patients wi...
Detailed Description
Diabetes patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain). Patients fulfilling the required criteria will be invited to p...
Eligibility Criteria
Inclusion
- Patients with diagnosed diabetes, for at least 1 year.
- Presence of a minimum of 18 teeth.
- Untreated stages II and III periodontitis with radiographic evidence of generalized alveolar bone loss higher than 30%, and presence of at least one pocket with probing pocket depth (PPD) higher than 5 mm per quadrant with bleeding on probing (BOP).
Exclusion
- Subgingival instrumentation within 12 months before baseline examination.
- Use of antibiotics in the three months prior to the study.
- Use of other probiotic products in the month prior the study.
- Systemic diseases that could affect the course of periodontitis or its treatment such as immunological disorders, excluding diabetes.
- Ongoing drug therapy influencing the evaluated clinical parameters (non-steroid inflammatory drugs, etc.).
- Compromised medical conditions requiring prophylactic antibiotic therapy (e.g. patients with valvular prostheses, patients with previous history of bacterial endocarditis, congenital heart diseases like shunts or heart transplant recipients who developed valvular heart disease)
- Pregnancy.
- Stage IV periodontitis, or acute periodontal conditions.
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04069611
Start Date
January 30 2020
End Date
December 31 2023
Last Update
June 1 2022
Active Locations (1)
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1
Faculty of Odontology
Madrid, Spain, 28040