The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis

Gingivitis Clinical Trial

Official title:

The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Threemonth Clinical Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430060
• Other study ID #: CRO-2024-03-GIN-DZN-CN-YPZ
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Colgate Palmolive
• Contact: Deyu Hu, DDS, MS
• Phone: 86-1390-803-4990
• Email: hudeyu[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2024
• Est. primary completion date: August 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).
• 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 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 which prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Pregnant or lactating subjects

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Plaque, Dental

Intervention

Drug:
• zinc containing toothpaste
Toothpaste
• MFP Fluoride toothpaste
toothpaste

Locations

Country	Name	City	State
China	West China Dental Institute of Chengdu	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loe-Silness Gingival Index score	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, 2 week, 6 week, 3 month
Primary	Quigley-Hein Plaque Index score	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, 2 week, 6 week, 3 month