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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06427499
Other study ID # CRO-2024-04-PGN-BKS-YPZ
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 2024
Est. completion date September 2024

Study information

Verified date May 2024
Source Colgate Palmolive
Contact Terdphong Triratana
Phone 66-81-311-3986
Email terdphong86@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Subjects, ages 18-70, inclusive. - Availability for the three-month duration of the clinical research study. - Good general health. - Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Stannous fluoride toothpaste
brush 2 min morning & night daily
Colgate Cavity Protection Toothpaste
brush 2 min morning & night daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Colgate Palmolive

Outcome

Type Measure Description Time frame Safety issue
Primary Loe and Silness Gingival Index. A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. baseline, one week, six weeks and three months
Primary Quigley and Hein Plaque Index A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. baseline, one week, six weeks and three months
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