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Completed

NCT Number: NCT06430060

Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Plaque and Gingivitis

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

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

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).
  • 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.
  • History of alcohol or drug abuse.
  • Pregnant or lactating subjects

Treatment and study plan

zinc containing toothpaste

Drug

Toothpaste

MFP Fluoride toothpaste

Drug

toothpaste

Primary outcomes

  1. Loe-Silness Gingival Index score

    Time frame: baseline, 2 week, 6 week, 3 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.

  2. Quigley-Hein Plaque Index score

    Time frame: baseline, 2 week, 6 week, 3 month

    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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Three Month Clinical Study)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Mar 19, 2026

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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