Study on Clinical Effects of Toothpaste Containing Propolis in Periodontitis Patients
Phase 2
- Conditions
- Periodontitis
- Registration Number
- JPRN-UMIN000029554
- Lead Sponsor
- Okayama University
- Brief Summary
Primary endpoints Total bacterial count: There was no significant difference between the control and propolis groups before and after the test. There was no significant difference in the number of Pg bacteria between the control and propolis groups before and after the test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergic for this toothpaste 2) Pregnancy or lactating period women 3) Unstable physical condition 4) Use of antibiotics / anti-inflammatory agents within 3 months 5) Acute symptom of periodontitis within 3 months 6) Smoker 7) Unifit patients judged by research dentists for compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amounts of bacteria in sub-gingival dental plaque after 4 weeks (Total bacteria and Porphyromonas gingivivalis)
- Secondary Outcome Measures
Name Time Method ine points after 4 weeks 1) Probing pocket depth 2) Bleeding on probing 3) Activity of neutrophil elastase and total protein amounts in saliva 4) Ammonia in saliva 5) Cariogenic activity of saliva: amounts of cariogenic bacteria, acidity, buffer capacity 6) Microflora of sub-gingival dental plaque analyzed by next generation sequencer (2 subjects/group) 7) Questionnaire for impression of use of this toothpaste and its effective 8) Record of implementation 9) Questionnaire for the condition of pre-existing disease