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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Bleeding Gum
• Intervention / Treatment: Other: Toothpaste containing 1.05% Chitosan; Other: Toothpaste with 67% bicarbonate; Other: Silica-based NaF Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Dental Institute of Chengdu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects, aged 18-70, inclusive.
2. Availability for the duration of the study.
3. 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.
4. Willingness to comply with all study procedures and clinical examination schedules.
5. 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).
6. Presence of a minimum of 20 natural teeth (excluding third molars) with facial and lingual scoreable surfaces.
7. Have a mean Modified Gingival Index (Lobene) ≥ 2.5 at screening.
8. Subjects reporting bleeding while routine toothbrushing.

Exclusion Criteria:

1. Pregnant or lactating.
2. Use of tobacco products.
3. History of alcohol or drug abuse.
4. 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.
5. Medical condition which requires pre-medication prior to dental visits/procedures.
6. History of allergy to oral hygiene products.
7. 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.
8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine).
9. Presence of orthodontic bands or removable partial denture(s).
10. Tumor (s) of the soft or hard tissues of the oral cavity.
11. Five or more carious lesions requiring immediate restorative treatment.
12. More than 2 periodontal pockets (>4mm deep) with bleeding on probing.
13. Any gingival condition like hyperplasia or overgrowth, that would cause difficulty in clinical assessment.
14. Participation in any other clinical study with an oral care indication or test panel within 30 days prior to the start of the study.
15. Existing medical condition which prohibits the subject from not eating or drinking for periods of up to 2 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Toothpaste containing 1.05% Chitosan, soft-bristled toothbrush	Other: Toothpaste containing 1.05% Chitosan; Toothpaste containing 1.05% Chitosan
Active Comparator: Positive control; Toothpaste containing 67% Bicarbonate, soft-bristled toothbrush	Other: Toothpaste with 67% bicarbonate; Toothpaste containing 67% Bicarbonate
Placebo Comparator: Negative control; Silica-based NaF Toothpaste, soft-bristled toothbrush	Other: Silica-based NaF Toothpaste; Silica-based NaF Toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Collaborators: West China Dental Institute of Chengdu

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Infections; Gingival Diseases; Hemorrhage; Gingivitis; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Chelating Agents; Sequestering Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chitosan
• Other Study ID Numbers: CRO-2024-11-BLD-CHT-MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No