Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan

NCT06955871 | Completed

• 1 other identifier: CRO-2024-11-BLD-CHT-MS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.

Conditions

Bleeding Gum; Gingivitis

Outcome Measures

Primary Outcomes (2)

• Gingival Bleeding

  Gingival Bleeding Index described by Saxton and van der Ouderaa (1989).

  From baseline to 3 days, 7 days and 14 days after baseline.

• Gingivitis

  Modified Gingival Index (MGI) Lobene et al (1986)

  Baseline, and immediately post-brushing

Study Arms (3)

Test

EXPERIMENTAL

Toothpaste containing 1.05% Chitosan, soft-bristled toothbrush

Other: Toothpaste containing 1.05% Chitosan

Positive control

ACTIVE COMPARATOR

Toothpaste containing 67% Bicarbonate, soft-bristled toothbrush

Other: Toothpaste with 67% bicarbonate

Negative control

PLACEBO COMPARATOR

Silica-based NaF Toothpaste, soft-bristled toothbrush

Other: Silica-based NaF Toothpaste

Interventions

Toothpaste containing 1.05% Chitosan OTHER

Toothpaste containing 1.05% Chitosan

Test

Silica-based NaF Toothpaste OTHER

Silica-based NaF Toothpaste

Negative control

Toothpaste with 67% bicarbonate OTHER

Toothpaste containing 67% Bicarbonate

Positive control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, aged 18-70, inclusive.
• Availability for the duration of the study.
• Ability to understand and willingness to read, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
• Willingness 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 constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements etc).
• Presence of a minimum of 20 natural teeth (excluding third molars) with facial and lingual scoreable surfaces.
• Have a mean Modified Gingival Index (Lobene) ≥ 2.5 at screening.
• Subjects reporting bleeding while routine toothbrushing.

You may not qualify if:

• Pregnant or lactating.
• Use of tobacco products.
• History of alcohol or drug abuse.
• Medical condition (especially, heart or liver problems, bleeding disorders, blood dyscrasias) or any current usage of medication that the investigator considers may compromise the subject safety, as well as, the quality of the study results.
• Medical condition which requires 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 in the 30 days prior to the start of the study and during the course of the study.
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine).
• Presence of orthodontic bands or removable partial denture(s).
• Tumor (s) of the soft or hard tissues of the oral cavity.
• Five or more carious lesions requiring immediate restorative treatment.
• More than 2 periodontal pockets (\>4mm deep) with bleeding on probing.
• Any gingival condition like hyperplasia or overgrowth, that would cause difficulty in clinical assessment.
• Participation in any other clinical study with an oral care indication or test panel within 30 days prior to the start of the study.
• Existing medical condition which prohibits the subject from not eating or drinking for periods of up to 2 hours.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Gingival Hemorrhage; Gingivitis

Interventions

Chitosan; Toothpastes; Bicarbonates

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: April 29, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)