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Completed

NCT Number: NCT02243046

The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

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Key information

Conditions

Dental Plaque and Gingivitis Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spa Dental

Santo Domingo, Dominican Republic

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 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 period 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 that prohibits eating or drinking for periods up to 4 hours.
  • History of alcohol or drug abuse.
  • Pregnant or lactating subjects.

Treatment and study plan

Control toothpaste

Drug

1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Other names: Max Fresh toothpaste

Experimental toothpaste

Drug

1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Active Comparator

Drug

1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Other names: Total toothpaste

Primary outcomes

  1. Gingivitis Scores

    Time frame: Baseline

    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  2. Gingivitis Scores

    Time frame: 3 months (from Baseline)

    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  3. Gingivitis Scores

    Time frame: 6 months (from Baseline)

    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  4. Dental Plaque Scores

    Time frame: Baseline

    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  5. Dental Plaque Scores

    Time frame: 3 months (from Baseline)

    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  6. Dental Plaque Scores

    Time frame: 6 months (from Baseline)

    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2014
Registry last updated
Feb 25, 2019

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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