The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

Gingivitis Clinical Trial

Official title:

The Clinical Investigation of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis: A Three-Month Study in Thailand

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427499
• Other study ID #: CRO-2024-04-PGN-BKS-YPZ
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Gingivitis
• Plaque

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