The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

NCT06427499 — Phase 3, Completed, 95 participants, Colgate Palmolive

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

The Clinical Investigation of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis: A Three-Month Study in Thailand

RegistryNCT06427499
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment95 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsPlaque, Gingivitis
InterventionsStannous fluoride toothpaste, Colgate Cavity Protection Toothpaste (Drug)
Datesstart 2024-04-22, primary completion 2024-08-05, completion 2024-08-05, first posted 2024-05-24, last updated 2026-03-19
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Plaque All trials for Gingivitis All trials of Stannous fluoride toothpaste All trials of Colgate Cavity Protection Toothpaste

-Summary

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Stannous Fluoride ToothpasteExperimentalDrug: Stannous fluoride toothpastebrush for 2 min, 2x/day, morning and night
Sodium monofluorophosphate toothpasteActive comparatorDrug: Colgate Cavity Protection Toothpastebrush for 2 min, 2x/day, morning and night
  • Stannous fluoride toothpaste (Drug): brush 2 min morning \& night daily
  • Colgate Cavity Protection Toothpaste (Drug): brush 2 min morning \& night daily

+Outcome measures

Primary outcomes

  • Loe and Silness Gingival Index. [baseline, one week, six weeks and three months]: A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.
  • Quigley and Hein Plaque Index [baseline, one week, six weeks and three months]: A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the three-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. 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.
* Pregnant or lactating subjects

+Locations (1)

FacilityCityCountryStatus
Mahidol UniversityRatchathewi, BangkokThailand

+Investigators