Clinical trial

Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

NCT05731778

Name

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

Description

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

Trial arms

Trial start

2018-12-22

Estimated PCD

2020-12-22

Trial end

2020-12-22

Status

Completed

Phase

Early phase I

Treatment

Stannous Fluoride Toothpaste

0.454% stannous fluoride toothpaste

Arms:

Stannous fluoride test toothpaste

Other names:

Colgate Total SF

Colgate fluoride toothpaste

0.76 % Sodium MonoFluorophosphate (MFP)

Arms:

Colgate flouride toothpaste

Other names:

Colgate Dental Cream

Size

Primary endpoint

Bleeding Index (BOP) and Oral Inflammatory Load

during patient visit over the 9 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

Updated at

2023-02-16

1 organization

2 products

1 indication

Product

Indication

Product

Organization