Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Colgate-Palmolive

Status and phase: Completed; Phase 4

Conditions: Gingivitis

Treatments: Drug: Stannous Fluoride Toothpaste; Drug: Colgate fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT05731778

CRO-2018-07-IND-GING-DELAY-JG

Details and patient eligibility

About

Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Full description

A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. No clinical signs of gingival inflammation at >90% sites observed
4. Probing Depth (PD) < 3.0 mm
5. Attachment Loss (AL) = 0 mm
6. No periodontal disease history
7. Non-smokers
8. Fluent in English

Exclusion criteria

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Tumour(s) of the soft or the hard tissues of the oral cavity.
4. Cavitated carious lesions requiring immediate restorative treatment.
5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
6. Participation in any other clinical study or test panel with a one month period prior to entering the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Stannous fluoride test toothpaste

Experimental group

Description:

Currently marketed as the new Colgate Total SF containing Stannous Fluoride

Treatment:

Drug: Stannous Fluoride Toothpaste

Colgate flouride toothpaste

Placebo Comparator group

Description:

Colgate Dental Cream containing Stannous Sodium Fluoride

Treatment:

Drug: Colgate fluoride toothpaste