A clinical study to investigate biomarkers from fluids of the oral cavity and the benefits on plaque and gingivitis reduction when using an electrical toothbrush with an irrigator
- Conditions
- Oral mild to moderate gingivitisOral HealthGingivitis and periodontal diseases
- Registration Number
- ISRCTN15360464
- Lead Sponsor
- Procter and Gamble Company
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33615769/ (added 17/03/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Be at least 18 years of age
2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form
3. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study
4. Agree to return for the scheduled clinical visits and follow study instructions
5. Agree not to participate in any other oral care study for the duration of this study
6. Agree not to use any non-study oral hygiene products for the duration of the study (including dental floss)
7. Agree to delay any elective dentistry, including dental prophylaxis (outside of the study protocol), until study completion
8. Agree to refrain from brushing their teeth and from performing any other oral hygiene procedures 12 hours prior to each visit
9. Agree to refrain from eating, chewing gum, drinking or using tobacco for 4 hours prior to each visit
10. Have at least 20 gradable teeth
11. Have at least 15 gingival bleeding sites (as described in section 13 - Löe & Silness GI)
1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
2. Active treatment for periodontitis
3. Fixed facial or lingual orthodontic appliances
4. Regular use of electric toothbrush
5. Need of antibiotic prophylaxis prior to the dental visit
6. Antibiotic use or prescription mouth rinse use within one month prior of Screening (Visit 1)
7. Dental prophylaxis within one month prior of Screening (Visit 1)
8. Any disease or condition that could be expected to interfere with the subject safely completing the study
9. Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gingival inflammation and bleeding measured by Gingival Index (Löe & Sillness 1963) at baseline, week 2, 4, and 8
- Secondary Outcome Measures
Name Time Method <br> Measured at baseline, week 2, 4, and 8:<br> 1. Gingivitis-associated oral fluid biomarkers: whole Saliva and GCF (both collected at the clinic) were quantitatively analyzed for the amount of matrix-metalloproteinase (MMP)-8 and interleukin (IL)-1ß by means of ELISA technique<br> 2. Dental plaque measured by Plaque Index (Silness-Löe 1964)<br>