None listed
Conditions
Interventions
Intervention1: Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monoflorophosphate: Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males and Non-pregnant (self-declared)/Non-Lactating female subjects of age 18 to 60 years (both inclusive) at the time of consent. 2) Subjects having good general health as determined by the Investigator based on medical history and vital signs. 3) Subjects with localized and generalized dentinal hypersensitivity (preferably with equal number of localized and generalized DH in each group) 4) Subjects with mild to moderate dental hypersensitivity (tested by thermal testing). 5) 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. 6) Subjects with eroded/damaged enamel (Grade 2 – 3 as per Ordinal scale for severity of dental erosion). 7) Subjects who are willing to participate in the study and give a signed consent. 8) 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 with orthodontic bands. 3) Subjects with partial removable dentures and fixed partial dentures. 4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity. 5) Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) 6) Subjects with history of treatment for dentin hypersensitivity 7) Poor periodontal condition 8) Subject who has used antibiotics any time during the one month prior to start of the study. 9) Subjects who consume alcohol. 10) Subjects smoking cigarette or consume any other form of tobacco. 11) Participation in a similar clinical study within the previous 30 Days. 12) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Group 1 1.To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha and cold spray for absent, mild, moderate or severe response recorded by the dentist at 2.To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at 2.To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) atTimepoint: baseline (30 mins before direct product application), 30 secs (+5 secs) after completion of brushing. Day 15 (+ 02 days), Day 30 (+ 02 days) and Day 60 (+ 02 days) after 30 secs (+5 secs) of completion of brushing. | — |
Secondary
| Measure | Time frame |
|---|---|
| For Group 1 To assess Subjective evaluation questionnaires on dental hypersensitivity. To assess Subjective evaluation questionnaires regarding general oral hygiene & dental healthTimepoint: baseline (30 mins before direct product application), Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after brushing. Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after completion of brushing.;For Group 1 To assess the effect of test product in terms of enamel protection by grading erosion using Ordinal scale for severity of dental erosion on buccal & lingual surfaces of maxillary anterior teethTimepoint: baseline (30 mins before direct product application), Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after completion of brushing.;For Group 2 To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha & cold spray for absent, mild, moderate or severe response recorded by the dentist atTimepoint: baseline (30 mins before direct brushing), 30 secs (plus 5 secs) after completion of brushing. Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after 30 secs (plus 5 secs) of completion of brushing.;For Group 2 To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) atTimepoint: baseline (30 mins before direct brushing), 30 secs (plus 5 secs) after completion of brushing. Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after 30 secs (plus 5 secs) of completion of brushing. | — |
Countries
India
Contacts
Public ContactDr. Sagar Katare
Dr. Reddy’s Laboratories Ltd.
Outcome results
None listed