clinical study to evaluate the effect of SILVERSOL TOOTH GEL in the management of Oro-dental hygiene.
- Registration Number
- CTRI/2022/01/039411
- Lead Sponsor
- Viridis BioPharma PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 115
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method