Clinical Efficacy Evaluation of Three Dentifrices

NCT03988374 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ST-7700
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy

  Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.

  baseline, six weeks, 3 months and 6 months

• Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy

  Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.

  baseline, six week, three months, and six months

• Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy

  Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5.

  baseline, six weeks, three months, and six months

Study Arms (3)

0% Baking Soda Dentifrice

ACTIVE COMPARATOR

Drug: Dentifrices

20% Baking Soda Dentifrice

ACTIVE COMPARATOR

Drug: Dentifrices

35% Baking Soda Dentifrice

ACTIVE COMPARATOR

Drug: Dentifrices

Interventions

Dentifrices DRUG

Dentifrice on plaque, gingivitis, and bleeding.

0% Baking Soda Dentifrice; 20% Baking Soda Dentifrice; 35% Baking Soda Dentifrice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L4W OC2, Canada

Location

MeSH Terms

Conditions

Gingivitis; Hemorrhage; Dental Plaque

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Annahita Ghassemi, PhD
• Organization: Church & Dwight Co., Inc

annhita.ghassemi@churchdwight.com

6098061200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: June 17, 2019
• Study Start: February 22, 2018
• Primary Completion: August 24, 2018
• Study Completion: August 24, 2018
• Last Updated: August 23, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)