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NCT Number: NCT07499115

Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival Bleeding

To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste

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Key information

Conditions

Plaque, Dental 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 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

  • Male or female, aged 18-70 years (inclusive).
  • Available for the duration of the study.
  • Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained.
  • Willing to comply with all study procedures and clinical examination schedules.
  • Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements).
  • Presence of at least 20 natural teeth (excluding third molars) with scorable facial and lingual surfaces.
  • Mean Modified Gingival Index (MGI, Lobene) ≥ 2.0 and Mean Modified Plaque Index (MPI, Turesky) ≥ 1.5 at screening.
  • Willing and able to complete study questionnaires on product usage experience during routine toothbrushing.

Exclusion criteria

  • Pregnant or lactating.
  • Use of tobacco products.
  • History of alcohol or drug abuse.
  • Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results.
  • Medical condition requiring pre-medication prior to dental visits/procedures.
  • History of allergy to oral hygiene products.
  • Use of anti-inflammatory, immunosuppressive, antimicrobial, or anticoagulant drugs, or antibiotics within 30 days prior to study start or during the study.
  • Ongoing use of medications known to affect gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
  • Presence of orthodontic bands or removable partial dentures.
  • Tumors of the soft or hard tissues of the oral cavity.
  • Five or more carious lesions requiring immediate restorative treatment.
  • More than two periodontal pockets (>4 mm) with bleeding on probing.
  • Any gingival condition (e.g., hyperplasia or overgrowth) that would interfere with clinical assessment.
  • Participation in another clinical study with an oral care indication or test panel within 30 days prior to study start.
  • Medical condition that prohibits abstaining from eating or drinking for up to 2 hours.

Treatment and study plan

Toothpaste containing chitosan

Drug

Toothpaste containing chitosan and a commercially available soft-bristled toothbrush

Colgate Cavity Protection Toothpaste

Drug

Fluoride Toothpaste and a commercially available soft-bristled toothbrush

Primary outcomes

  1. Modified Gingival Index (MGI_ Lobene)

    Time frame: Baseline, 2 week, 1 month & 3 month

    Clinical assessments will be carried out using the Modified Gingival Index (MGI; Lobene et al., 1986).MGI scoring criteria: 0: Absence of inflammation

    • Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit
    • Mild inflammation; as above, but involving the entire marginal or papillary gingival unit
    • Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit
    • Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration

  2. Modified Plaque Index (MPI_ Turesky)

    Time frame: Baseline, 2 week, 1 month & 3 month

    Using a red disclosing solution, a Modified Plaque Index (Turesky et al, 1970) score of 0-5 will be assigned to all scorable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.

    A whole-mouth score will be determined by summing the values for all scorable surfaces and dividing by the total number of surfaces scored.

    Modified Plaque Index (Turesky) scoring criteria:

    0: No plaque

    • Separate flecks of plaque at the cervical margin
    • A thin, continuous band of plaque (up to 1 mm) at the cervical margin
    • A band of plaque wider than 1 mm but covering less than one-third of the crown
    • Plaque covering at least one-third but less than two-thirds of the crown
    • Plaque covering two-thirds or more of the crown

  3. Gingival Bleeding Index (GBI_ Saxton)

    Time frame: Baseline, 2 week, 1 month & 3 month

    The examiner will conduct the Gingival Bleeding Index (GBI) examinations using the Saxton and van der Ouderaa methodology and a CPITN periodontal probe (0.5 mm ball end). Findings and GBI score calculations (including bleeding severity) will be recorded on the Gingival Bleeding Index Examination Form.

Study contacts

Contact information is provided by the study sponsor or research team.

Deyu Hu, DDS

CONTACT

[email protected]

1390-803-4990

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation of the Efficacy of a Toothpaste Containing Chitosan in Reducing Plaque, Gingivitis, and Gingival Bleeding

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 13, 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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