Status:
COMPLETED
Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingivitis
Plaque
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducin...
Eligibility Criteria
Inclusion
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of 20 uncrowned 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 plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
- Signed Informed Consent Form
Exclusion
- Presence of orthodontic bands.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- 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 or drinking for periods up to 4 hours.
- History of alcohol or drug abuse.
- Pregnant or lactating subjects.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06563518
Start Date
January 18 2022
End Date
July 10 2022
Last Update
August 21 2024
Active Locations (1)
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1
Mahidol University
Ratchathewi, Bangkok, Thailand, 10400