Clinical Efficacy Evaluation of Three Dentifrices

NCT ID: NCT03988374

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2018-08-24

Brief Summary

Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use.

Conditions

Gingival Inflammation and Bleeding; Dental Plaque

Study Design

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

Study Groups

0% Baking Soda Dentifrice

Group Type: ACTIVE_COMPARATOR

Dentifrices

Intervention Type: DRUG

Dentifrice on plaque, gingivitis, and bleeding.

20% Baking Soda Dentifrice

Group Type: ACTIVE_COMPARATOR

Dentifrices

Intervention Type: DRUG

Dentifrice on plaque, gingivitis, and bleeding.

35% Baking Soda Dentifrice

Group Type: ACTIVE_COMPARATOR

Dentifrices

Intervention Type: DRUG

Dentifrice on plaque, gingivitis, and bleeding.

Interventions

Dentifrices

Dentifrice on plaque, gingivitis, and bleeding.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have provided written informed consent prior to being entered into the study.
• Be between 18 and 70 years of age, male or female.
• Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as determined by the Examiner. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be included in the tooth count.
• Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl).
• Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the Modified Gingival Index (MGI).
• Presence of ≥ 10 bleeding sites upon probing.
• Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study.
• Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study.
• Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking, and smoking for 4 hrs, prior to each evaluation visit.
• Agree to comply with the conditions and schedule of the study.

Exclusion Criteria

• Physical limitations or restrictions that might preclude normal tooth brushing.
• Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, preexisting gross plaque or soft or hard tissue tumor of the oral cavity.
• Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the Investigator/Examiner.
• Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
• Conditions requiring antibiotic treatment prior to dental procedures.
• History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS).
• Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
• Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial.
• Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) within 1 month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
• Have severe periodontal disease or being actively treated for periodontal disease.
• Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis.
• Concomitant periodontal therapy other than prophylaxis in the last 6 months.
• Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
• Subjects who participated in a gingivitis study in the past month.
• Daily use of chemotherapeutic antiplaque/antigingivitis products within the past 4 months.
• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
• Subjects who are allergic to any ingredients in the test or control product, as listed on the IRB Safety Assessment.
• Self-reported pregnancy and nursing since hormonal changes can exaggerate gingival response to dental plaque.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

All Sum Research Center Ltd.

Mississauga, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ST-7700

Identifier Type: -

Identifier Source: org_study_id