Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Presence of a minimum of 20 teeth 2.Presence of tooth sensitivity 3.Adequate oral hygiene and no sign of oral neglect 4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale 5.Use of a non-desensitizing dentifrice for one month prior to entry into the study
Exclusion criteria
Exclusion criteria: 1.Professional teeth cleaning and whitening less than 30 days before the examination. 2.Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study. 3.The use of analgesic agents less than 7 days prior to inclusion 4.Untreated dental caries or active periodontal disease . 5.Presence of cracked, chipped, or fractured teeth. 6.Severe enamel loss, dentin exposure, or pulpitis 7.Teeth whitening, scaling, or polishing within the past 4 6 weeks. 8.Recent restorations or oral surgeries that could influence sensitivity. 9.Regular use of desensitizing toothpaste or treatments within the past 4 weeks 10.Use of prescription fluoride treatments or other dental products specifically targeting sensitivity 11.Conditions affecting oral health, such as diabetes, GERD. 12.Excessive consumption of acidic foods or beverages. 13.Heavy tobacco or alcohol use that could affect oral health or study results. 14.History of bruxism, clenching, or other habits that could increase tooth wear. 15.Known allergies to any components of the products being tested. 16.Conditions or medications that might interfere with the perception of sensitivity. 17.Participation in any other clinical study or test panel within one month prior to entry into the study. 18.History of Hepatitis B or C, HIV infection. 19.Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study. 20.Pregnant or lactating participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ). 2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain. 3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S). 4.Air Blast Hypersensitivity. 5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air Response is rated based on the Schiff Cold Air Sensitivity Scale Response is rated based on the Schiff Cold Air Sensitivity Scale. 6.Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity. 7.Photographic assessment of dental hygiene.Timepoint: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study. 2.Adverse event monitoring.Timepoint: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4) | — |
Countries
India
Contacts
KI3 PRIVATE LIMITED