Status:
ACTIVE_NOT_RECRUITING
Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.
Lead Sponsor:
Colgate Palmolive
Conditions:
Plaque, Dental
Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the ...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form.
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the six-week duration of the clinical research study.
- Good general health based on the opinion of the study investigator
- Minimum of 20 permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- Initial mean plaque index of at least 0.6 as determined by Navy Plaque index.
Exclusion
- Presence of orthodontic appliances.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one-month period prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome.
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- History of alcohol and/or drug abuse.
- Self-reported pregnancy and/or lactating subjects.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06565897
Start Date
July 26 2024
End Date
September 1 2024
Last Update
August 22 2024
Active Locations (1)
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1
Consumer Research Consulting, LLC
Melbourne, Florida, United States, 32940