None listed
Conditions
Interventions
Intervention1: Silversol tooth gel: Apply the GEL as a thin layer on the gums twice daily using a finger or swab.
Avoid drinking or eating for 30 minutes after applying the gel.
Treatment duration wi
Sponsors
Viridis BioPharma PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both males and females of age above 18 years without any known allergy to commercial dental products or cosmetics 2. Subject who meets anyone of the following criteria Tooth sensitivity tooth decay fractured teeth, worn fillings, worn tooth enamel, exposed tooth root gingivitis, Periodontitis All dental concerns including bleeding gum, dental plaque calculus or tar tar, deep scaling and Gingival curettage 3. Subjects are screened for oral health by dentists using Oral Health Assessment Tool for Dental Screening 4.Good general health with in the opinion of the investigator no clinically significant and relevant abnormalities of medical history or oral or dental examination. 5.Absence of significant oral soft tissue pathology, based on the dentists visual examination and at the discretion of the investigator. 6. Moderate gingivitis present at the screening visit in the opinion of the investigator 7. Post tooth extraction or any post surgical condition 8. Mentally, physically and legally eligible to give informed consent.
Exclusion criteria
Exclusion criteria: 1 Subjects with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity. 2. Subjects with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain. 3. Subjects who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit. 4. Use of desensitizing agents whether prescribed or over-the-counter within eight weeks prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity, Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care products used for the treatment of dentinal hypersensitivity). 5. Subjects who during the study will receive dental treatment which may affect their dentinal hypersensitivity condition (i.e., oral prophylaxis). Emergency treatment will be allowed. 6. Dental prophylaxis within 2 weeks prior to Screening visit. 7. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of change in Breath odor from the screening to End Of the treatment using a hedonic malodour evaluation (Odour evaluation sheet) 2.Evaluation of the changes in deep tooth stains from screening to EOT by Lobene Stain index 3.Reduction in plaque formation in the mouth from baseline to EOT 4.Reduction in pocket depth in Periodontitis is measured by the instrument (periodontal probe) and assessed by using the scale Timepoint: From day 1 to day 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in overall oral health performance as assessed by Oral Health Assessment Tool for Dental Screening and Oral care Assessment Guide from baseline to EOT. 2.Reduction in gingival index 3.Incidence and Rate of adverse events Timepoint: From day 1 to day 24 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed