Bleeding, Gingival Inflammation, Plaque
Conditions
Brief summary
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period. A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
Interventions
Comparator toothpaste
Test toothpaste (0.454% SnF)
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects aged 18 to 65 years (inclusive) * Provided written informed consent prior to participation * Able to brush their own teeth on a daily basis * In good general health based on medical history review * Minimum of at least 18 natural, scorable teeth * Mean plaque index score ≥ 1.95 * Mean baseline gingival index score ≥ 1.70 and ≤ 3.0 * Agreed to refrain from use of all oral hygiene products other than those supplied for the study * Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits * Agreed not to undergo dental prophylaxis or elective dental procedures during the study * Willing and able to comply with study procedures and visit schedule
Exclusion criteria
* Physical limitations or restrictions that preclude normal tooth brushing * Requirement for premedication prior to dental treatment * Pregnancy or intent to become pregnant during the study period * Use of tobacco or nicotine products * Poor oral hygiene defined as \>40 bleeding sites * Presence of dental caries or calculus deposits that may interfere with plaque assessments * Major oral hard or soft tissue lesions or trauma at baseline * Presence of fixed or removable orthodontic appliances * Dental prophylaxis within 1 month prior to baseline visit * History of significant adverse events, allergy, or irritation related to oral hygiene products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation | 12 weeks | Change from baseline in whole-mouth Modified Gingival Index (MGI) score at Week 12 Whole-mouth gingival inflammation will be assessed using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. The primary analysis compares the change from baseline to Week 12 between treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate improvements at weeks 2, 4, 8; assess gingival bleeding at weeks 2, 4, 8, and 12 weeks | 2, 4, 8, and 12 weeks | Secondary outcome measures include change from baseline in whole-mouth bleeding index at Weeks 2, 4, 8, and 12...based on scorable gingival areas using the Saxton 0-2 scale |
| Evaluate improvements at weeks 2, 4, 8; assess plaque control at weeks 2, 4, 8, and 12 weeks | 2, 4, 8, and 12 weeks | Secondary outcome measures include change from baseline in plaque at Weeks 2, 4, 8, and 12...calculated from disclosed plaque scores on scorable buccal and lingual tooth surfaces using the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index; lower scores indicate improvement for all measures. |
| Evaluate improvements at weeks 2, 4, 8; in whole mouth Modified Gingival Index (MGI) scores | 2, 4, and 8 weeks | Secondary outcome measures include change from baseline in whole-mouth MGI at Weeks 2, 4, and 8, using the Modified Gingival Index (MGI). Scores are recorded on scorable gingival areas of all scorable teeth using a 0-4 scale, and the whole-mouth MGI score is calculated as the sum of all site scores divided by the number of scorable sites examined. |
Countries
Canada
Contacts
STUDY_DIRECTORAnnahita Ghassemi
Church & Dwight, Inc.
Outcome results
None listed