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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2025-06-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Bleeding Gum Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded

Study Groups

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Test

Toothpaste containing 1.05% Chitosan, soft-bristled toothbrush

Group Type EXPERIMENTAL

Toothpaste containing 1.05% Chitosan

Intervention Type OTHER

Toothpaste containing 1.05% Chitosan

Positive control

Toothpaste containing 67% Bicarbonate, soft-bristled toothbrush

Group Type ACTIVE_COMPARATOR

Toothpaste with 67% bicarbonate

Intervention Type OTHER

Toothpaste containing 67% Bicarbonate

Negative control

Silica-based NaF Toothpaste, soft-bristled toothbrush

Group Type PLACEBO_COMPARATOR

Silica-based NaF Toothpaste

Intervention Type OTHER

Silica-based NaF Toothpaste

Interventions

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Toothpaste containing 1.05% Chitosan

Intervention Type OTHER

Silica-based NaF Toothpaste

Intervention Type OTHER

Toothpaste with 67% bicarbonate

Toothpaste containing 67% Bicarbonate

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No