None listed
Conditions
Interventions
Intervention1: Toothpaste: Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of 1 month for group A and 3 months for group B.
Intervention2: Toothpaste:
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males and Non-pregnant /Non-Lactating female subjects of age 18 to 60 years (both inclusive) at the time of consent. 2) Subjects with localized and generalized dentinal hypersensitivity. 3) Subjects with moderate to severe (4 - 9) dental hypersensitivity based on VAS scale (tested by thermal testing). 4) Subjects complaining of dentinal hypersensitivity following a cold stimulus such as ice cream, iced drink, or a rapid jet of cool air to a particular tooth or teeth. 5) Subjects having good general health as determined by the Investigator based on medical history, physical & dental examination and vital signs. 6) Subjects who are willing to participate in the study and give a signed consent. 7) Subjects should be willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding or planning pregnancy during the study period. 2) Subjects not willing to follow all the acceptable forms of contraception as applicable. 3) Subjects with dental caries. 4) Subjects with gingival index score more than 1 5) Subjects with a clinical mobility score more than 1 6) Subjects with eroded/damaged enamel (Grade more than 3 as per Ordinal scale for severity of dental erosion). 7) Subjects who are due for periodontal surgery. 8) Subjects with orthodontic bands and partial removable or fixed partial dentures. 9) Subjects having tumor(s) of the soft or hard tissues of the oral cavity. 10) Subject with advanced periodontal disease (purulent exudate, tooth mobility, and / or extensive loss of periodontal attachment or alveolar bone). 11) Subjects with history of treatment for dentin hypersensitivity. 12) Subjects who have used other dental hypersensitivity products like toothpastes, mouth wash or any dental treatments (fluoride treatments and dental sealants) to reduce dental hypersensitivity during the one month prior to start of the study. 13) Poor periodontal condition 14) Subjects who have used antibiotics any time during the one month prior to start of the study. 15) Subjects who consume alcohol. 16) Subjects smoking cigarette or consume any other form of tobacco. 17) Participation in a similar clinical study within the previous 30 Days. 18) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Dentinal hypersensitivity using different stimuli (air blast and tactile) between 2 groups.Timepoint: Day 30 (+ 02 days), Day 120 (+ 02 days) and Day 210 (+ 02 days) Vs Day 90 (+ 02 days), Day 180 (+ 02 days) and 270 (+ 02 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Dentinal hypersensitivity using different stimuli (air blast and tactile)Timepoint: Group A: Day 00, Day 30, Day 120 & Day 210 Group B: Day 00, Day 90, Day 180 & Day 270;Assessment of self-perceived sensitivity score by subjects using visual analog scale (VAS).Timepoint: Group A: Day 00, Day 30, Day 120 & Day 210 Group B: Day 00, Day 90, Day 180 & Day 270;Assessment of subject reported recurrence/episodes of Dentinal hypersensitivity throughout the follow-up period and re-treatment for recurrence on.Timepoint: Group A: Day 120 & Day 210 Group B: Day 180 & Day 270;Subjective evaluation questionnairesTimepoint: Group A: Day 00, Day 30, Day 120 & Day 210 Group B: Day 00, Day 90, Day 180 & Day 270 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Dr Reddys Laboratories Limited
Outcome results
None listed