Clinical Study Examining the Control of Plaque and Gingivitis

NCT07842978 — Phase 3, Not yet recruiting, 135 participants, Colgate Palmolive

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A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis

RegistryNCT07842978
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment135 (Estimated)
SponsorColgate Palmolive (Industry)
ConditionsGingivitis
InterventionsSilica Free Meridol, Meridol, Colgate Dental Product (Drug)
Datesstart 2026-10-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-09-25, last updated 2026-09-25
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Gingivitis All trials of Silica Free Meridol All trials of Meridol

-Summary

The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.

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+Arms and interventions

ArmTypeInterventionsDescription
Test 1 toothpasteExperimentalDrug: Silica Free MeridolSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
Test 2 toothpasteActive comparatorDrug: MeridolSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
Test 3 toothpasteActive comparatorDrug: Colgate Dental ProductSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.
  • Silica Free Meridol (Drug): Toothpaste
  • Meridol (Drug): Toothpaste
  • Colgate Dental Product (Drug): MFP fluoride toothpaste

+Outcome measures

Primary outcomes

  • Gingivitis Assessment [Baseline, 3 month, 6 month]: 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. 0 = Absence of inflammation 1. = Mild inflammation - slight change in color and little change in texture 2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy 3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.
  • Quigley-Hein Plaque Index [Baseline, 3 month, 6 month]: First using a red solution to dye the plaque, 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 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 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 which prohibits eating or drinking for periods up to 4 hours.

+Locations (1)

FacilityCityCountryStatus
West China Dental Institute of ChengduChengdu, SichuanChina

+Investigators

  • Deyu Hu, DDS, MS, Principal investigator, West China Dental Institute of Chengdu