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Completed

NCT Number: NCT05731778

Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

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

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Toronto

Toronto, Ontario, M5S, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

stannous fluoride toothpaste

Drug

0.454% stannous fluoride toothpaste

Other names: Colgate Total SF

Colgate fluoride toothpaste

Drug

0.76 % Sodium MonoFluorophosphate (MFP)

Other names: Colgate Dental Cream

Primary outcomes

  1. Bleeding Index (BOP) and Oral Inflammatory Load

    Time frame: during patient visit over the 9 weeks

    BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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