Health TrialsbyHealthPanel

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

ConditionsPlaque, DentalGingivitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Test ToothpasteExperimental treatment 1 intervention
Group B: Control ToothpasteActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Gingival Index (MGI_ Lobene)

Clinical assessments will be carried out using the Modified Gingival Index (MGI; Lobene et al., 1986).MGI scoring criteria: 0: Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit 2. Mild inflammation; as above, but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration

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

Modified Plaque Index (MPI_ Turesky)

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 1. Separate flecks of plaque at the cervical margin 2. A thin, continuous band of plaque (up to 1 mm) at the cervical margin 3. A band of plaque wider than 1 mm but covering less than one-third of the crown 4. Plaque covering at least one-third but less than two-thirds of the crown 5. Plaque covering two-thirds or more of the crown

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

Gingival Bleeding Index (GBI_ Saxton)

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colgate Palmolive

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: