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

NCT ID: NCT06430060

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-08-31

Brief 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.

Conditions

Plaque, Dental; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Colgate Dual Zinc Toothpaste

toothpaste

Group Type: EXPERIMENTAL

zinc containing toothpaste

Intervention Type: DRUG

Toothpaste

Colgate Cavity Protection Toothpaste

toothpaste

Group Type: ACTIVE_COMPARATOR

MFP Fluoride toothpaste

Intervention Type: DRUG

toothpaste

Interventions

zinc containing toothpaste

Toothpaste

Intervention Type: DRUG

MFP Fluoride toothpaste

toothpaste

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deyu Hu, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

West China Dental Institute of Chengdu

Locations

West China Dental Institute of Chengdu

Chengdu, Sichuan, China

Countries

China

Central Contacts

Deyu Hu, DDS, MS

Role: CONTACT

hudeyu@vip.sina.com

86-1390-803-4990

Other Identifiers

CRO-2024-03-GIN-DZN-CN-YPZ

Identifier Type: -

Identifier Source: org_study_id