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Not yet recruiting NCT07499115

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

Phase III Interventional Plaque, Dental Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toothpaste containing chitosan, Colgate Cavity Protection Toothpaste.
Who it may be relevant to
Registry conditions: Plaque, Dental, Gingivitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Toothpaste containing chitosan
    Toothpaste containing chitosan and a commercially available soft-bristled toothbrush
  • Drug Colgate Cavity Protection Toothpaste
    Fluoride Toothpaste and a commercially available soft-bristled toothbrush

Primary outcome measures

  • Modified Gingival Index (MGI_ Lobene) [Time frame: Baseline, 2 week, 1 month & 3 month]
  • Modified Plaque Index (MPI_ Turesky) [Time frame: Baseline, 2 week, 1 month & 3 month]
  • Gingival Bleeding Index (GBI_ Saxton) [Time frame: Baseline, 2 week, 1 month & 3 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Dental Institute of Chengdu — Chengdu

Identifiers

NCT: NCT07499115 · CRO-2025-10-PGB-CHT-YPZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗