CTRI/2010/091/000617
Completed
未知
Clinical evaluation of oral health parameters amongst adult subjects.
SDM College of Dental Sciences Hosptial Dharwad0 sites175 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SDM College of Dental Sciences Hosptial Dharwad
- Enrollment
- 175
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males and females in good general health aged 18 to 70 years.
- •2\.A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
- •3\.A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- •4\.Adequate oral hygiene and no signs of oral neglect.
Exclusion Criteria
- •1\.History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
- •2\.Gagging or other reflexes that prevent oral examination.
- •3\.History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- •4\.History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- •5\.Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam.
- •6\.Significant oral soft tissue pathology, systemically related gingival enlargement, (based on visual examinations).
- •7\.History of active severe periodontal disease with bleeding gums and loose teeth.
- •8\.Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations) will not be included in the tooth count.
- •9\.Fixed or removable orthodontic appliance or removable partial dentures.
- •10\.Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.
Outcomes
Primary Outcomes
Not specified
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