Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
None listed
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects in age group 18 â?? 55 years (both the ages inclusive). 2.Having at least 16 natural, permanent teeth. 3.Subjects with poor dental hygiene (self-reported and clinically diagnosed) 4.Subjects who have plaque and dental caries. (Caries score up to 2 using International Caries Detection and Assessment System (ICDAS). 5.Subjects with extrinsic dental stains (Score up to 2 using Lobene Stain Index) 6.Subjects willing to give their oral swab samples for analysis. 7.Subjects willing to come for follow up visits at the specified time. 8.Subjects ready to follow study related procedures during the study period. 9.Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
Exclusion criteria
Exclusion criteria: 1.A known history or present condition of hypersensitivity to any toothpaste and tooth powder 2.Subjects taking any supplementation known to support teeth health which may interfere study results. 3.The use of antibiotic, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month. 4.Any history of periodontal therapy by surgical interventions. 5.Subjects with active periodontal conditions. 6.Subjects who have used any medicated/fluoridated toothpastes. 7.Orthodontic treatment with fixed appliances. 8.Any removable device such as a removable partial denture or orthodontic retainer. 9.The presence of any fixed appliance, large or defective restorations, cracked enamel, 10.Subjects who have a history of smoking or use smokeless tobacco products/betel chewing 11.Subjects who are pregnant or lactating 12.Subjects having severe level of calculus and/ tartar. 13.Any underlying systemic illnesses, medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, a positive HIV status, hepatitis etc.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢Reduction in teeth stains â?¢Reduction in malodour causing bacteria â?¢Improvement in teeth colour â?¢Reduction in Plaque Index. â?¢Reduction in halitosis basis VSC (Volatile Sulphur Compounds) scores (Oral chroma) â?¢Reduction in gingival index â?¢Change in Teeth colour using Vita Shade Guide assessment and Image analysis. â?¢Reduction in Lobene stain index -Demineralization of teeth using Imaging in comparison to the baseline and with comparator product (exploratory)Timepoint: Day 1 and day 30 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in teeth health basis dental examination (Teeth surface, Plaque and Caries) with regular use of study product in comparison to the baseline and with White toothpaste 2. Improvement in gum health (colour, consistency, gum bleeding) as per the dental examination (Gingiva) with regular use of study product in comparison to the baseline and with White toothpasteTimepoint: Day 1 and Day 30 | — |
Countries
India
Contacts
Public ContactRitambhara
Dabur Research and Development Centre
Outcome results
None listed