- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852056
The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.
Qualified subjects will be enrolled and randomized to either one of the two study groups 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 and six months of product use. All subjects will be followed for adverse events throughout the study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Dental Institute of Chengdu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects, ages 18-70, inclusive.
- Availability for the six-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 period 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 that prohibits eating or drinking for periods up to 4 hours.
- History of alcohol or drug abuse.
- Self-reported pregnant or lactating subjects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: MFP Fluoride toothpaste
Commercially available, monofluorophosphate (MFP) toothpaste.
Fluoride level is 0.76%
|
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Other Names:
|
EXPERIMENTAL: Stannous Fluoride Toothpaste
New toothpaste containing 0.454% stannous fluoride.
|
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental Plaque Scores
Time Frame: Baseline
|
Quigley-Hein, Turesky Modification Index.
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
|
Baseline
|
Dental Plaque Scores
Time Frame: 3 month
|
Quigley-Hein, Turesky Modification Index.
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
|
3 month
|
Dental Plaque Scores
Time Frame: 6 month
|
Quigley-Hein, Turesky Modification Index.
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
|
6 month
|
Gingivitis Scores
Time Frame: Baseline
|
Loe & Silness Gingival Index.
Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy.
Tendency to bleed upon probing.
3 = Severe inflammation-marked redness and hypertrophy.
Tendency to spontaneous bleeding)
|
Baseline
|
Gingivitis Scores
Time Frame: 3 months
|
Loe & Silness Gingival Index.
Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy.
Tendency to bleed upon probing.
3 = Severe inflammation-marked redness and hypertrophy.
Tendency to spontaneous bleeding)
|
3 months
|
Gingivitis Scores
Time Frame: 6 months
|
Loe & Silness Gingival Index.
Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy.
Tendency to bleed upon probing.
3 = Severe inflammation-marked redness and hypertrophy.
Tendency to spontaneous bleeding)
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRO-2017-02-GIN-SNDZ-YPZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gingivitis
-
Zainab J AbbasCompleted
-
University of SaskatchewanCompletedChronic Gingivitis | Chronic Gingivitis, Plaque InducedCanada
-
Tufts UniversityGuangdong Bixdo Health Technology Co., Ltd.Not yet recruitingPlaque Induced GingivitisUnited States
-
Cairo UniversityNot yet recruiting
-
Hospital Universiti Sains MalaysiaRecruitingGingivitis | Plaque Induced GingivitisMalaysia
-
Lander Enterprises, LLCCompletedPlaque Induced GingivitisUnited States
-
University of WashingtonColgate PalmoliveCompleted
-
Tokat Gaziosmanpasa UniversityAbant Izzet Baysal UniversityCompletedPregnancy Gingivitis
-
Maharishi Markendeswar University (Deemed to be...CompletedChronic GingivitisIndia
-
Kırıkkale UniversityCompletedSmoking | Gingivitis; Chronic
Clinical Trials on MFP Fluoride toothpaste
-
Colgate PalmoliveCompleted
-
University of Campinas, BrazilCompleted
-
Colgate PalmoliveWithdrawn
-
University of MichiganEnrolling by invitationDental CariesUnited States
-
Colgate PalmoliveWithdrawn
-
University of ZagrebUniversity of Split, School of MedicineRecruiting
-
University of LeedsCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
GlaxoSmithKlineCompleted