Plaque, Dental, Gingivitis
Conditions
Brief summary
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
Interventions
DRUGToothpaste containing chitosan
Toothpaste containing chitosan and a commercially available soft-bristled toothbrush
Fluoride Toothpaste and a commercially available soft-bristled toothbrush
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Gingival Index (MGI_ Lobene) | Baseline, 2 week, 1 month & 3 month | 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 |
| Modified Plaque Index (MPI_ Turesky) | Baseline, 2 week, 1 month & 3 month | 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 |
| Gingival Bleeding Index (GBI_ Saxton) | Baseline, 2 week, 1 month & 3 month | 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. |
Countries
China
Contacts
CONTACTDeyu Hu, DDS
PRINCIPAL_INVESTIGATORDeyu Hu
West China Dental Institute of Chengdu
Outcome results
None listed