Clinical trial NCT03214406: Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis
Official title: Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Gingivitis
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Have provided written informed consent prior to being entered into study
* Have at least 18 scorable natural teeth as determined by the examiner
* Have a mean baseline plaque index score greater than or equal to 2.0 as determined by the Soparkar Modification of the Turesky modification of the Quigley-Hein Plaque Index
* Have a mean baseline gingival index score of greater than 1.80 as determined by the Modified Gingival Index
* Presence of greater than 10 bleeding sites upon probing
* Agree not to have dental prophylaxis or any other elective, no -emergency dental procedures (other than those provided during the study) any time during the study
* Agree to abstain from use of floss, 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 and drinking for 4 hours 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, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
* Heavy calculus that might interfere with evaluations as determined by the Investigator/Examiner
* Chronic disease with concomitant oral manifestations
* Conditions requiring antibiotic prophylaxis prior to invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants
* History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases (eg cardiovascular disease, AIDS)
* Subjects with fixed or removable orthodontic appliances or removable partial dentures
* Subjects who are currently undergoing, or require, extensive dental work or orthodontic treatment
* 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 baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment
* Moderately advanced to advanced periodontitis as indicated by clinical attachment loss, radiographic alveolar bone loss, and/or periodontal pockets greater than 5 millimeters
* Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis
* Concomitant endodontic or periodontal therapy other than prophylaxis in the last 6 months
* Professional prophylaxis within 1 month prior to the baseline clinical evaluation
* Currently using bleaching trays
* Currently using power toothbrush
* Currently a smoker or recently (during the past 6 months) quit smoking
* Having any oral piercings in or around the oral cavity with ornament or accessory
* Regular use of any chemotherapeutic antiplaque/antigingivitis products such as Colgate Total, Crest Pro-Health, Listerine, etc
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses
* Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study

Primary outcomes:
measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy
timeFrame: 16 weeks
measure: Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy
timeFrame: 16 weeks
measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: BioSci Research Canada, Ltd
state: Ontario
Study officials:
References: