None listed
Conditions
Interventions
Intervention1: Restosmile Dental Care: A pea-sized amount of the restosmile dental care toothpaste twice daily for a minimum of two minutes per brushing session for 14 days.
Control Intervention1: NA:
Sponsors
Aurora Nutraceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and non pregnant or non lactating females between 18 and 70 years of age. 2.Participants with a self reported history of dentinal hypersensitivity. 3.Presence of localized or generalized dentinal hypersensitivity. 4.At least one or two teeth exhibiting sensitivity in response to stimuli. 5.Demonstrate sensitivity to evaporative air stimulus (e.g., Schiff sensitivity score more than or equal to 2). 6.Good general and oral health, with a minimum number of natural teeth (e.g., 20). 7.Willing and able to participate in the study, follow the protocol, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of conditions causing pain similar to DH, such as active dental caries, heavily restored or fractured teeth, pulpitis, or extensive loss of periodontal attachment/alveolar bone. 2. Participants with orthodontic or prosthetic appliances that interfere with evaluation. 3. Participants who have used desensitizing treatments (including toothpastes or mouthwashes) or received professional desensitizing procedures within a specified periodprior to baseline (e.g., two weeks to six months). 4. Participants who have undergone vital teeth bleaching within a specified period prior to screening (e.g., two weeks). 5. Participants taking medication that could affect pain perception (e.g., daily analgesics, anti-inflammatory drugs) or antibiotics within a specified period. 6. Participants with a known history of hypersensitivity or allergy to ingredients in the restosmile dental care toothpaste. 7. Participants who consume tobacco or alcohol. 8. Suspected inability or unwillingness to comply with study procedures. 9. Presence of oral processes or habits that keep dentinal tubules exposed, such as poor plaque control, enamel wear, cervical erosion, or incorrect oral hygiene technique. 10. Diagnosis of specific diseases that cause gingival loss, such as necrotizing ulcerative gingivitis (NUG), periodontitis, or herpetic gingivostomatitis. 11. Recent crown preparation that may expose dentinal tubules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in dentinal hypersensitivity from baseline using objective and subjective assessments. 1.1.Thermal Test (Air Blast): Change in Visual Analogue Scale (VAS) score (0 10 scale) and categorical Schiff sensitivity scale. 1.2.Tactile Test: Change in Visual Analogue Scale (VAS) score (0 10 scale)and force in grams (using a Yeaple probe).Timepoint: 1.Screening, Day 07, Day 14. 2.Screening, Day07, Day 14. 3.Screening, Day07, Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Daily diary or questionnaire to record the frequency and severity of sensitivity in daily activities. 2.Change in total DHEQ-15 score and scores within each of the five domains (daily functional restrictions, coping behaviours, personal identity, social impact, and emotional impact). 3.Change in overall subjective rating of dentinal hypersensitivity of the entire dentition on a 0-10 scale. 4.Participant feedback will be collected through a structured questionnaire at the end of study.Timepoint: 1.Screening, Day 07, Day 14. 2.Screening, Day07, Day 14. 3.Screening, Day07, Day 14. 4.Day 14. | — |
Countries
India
Contacts
Public ContactMr Purushotam
Auriga Research Private Limited
Outcome results
None listed