A Prospective, Interventional, Randomized, Triple arm, Parallel, Controlled clinical study to evaluate the Efficacy & Safety of SILVERSOL TOOTH GEL in the management of Oro-dental hygiene.

Viridis BioPharma PvtLtd0 个研究点目标入组 115 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•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
•Tooth sensitivity tooth decay fractured teeth,
•worn fillings, worn tooth enamel, exposed tooth
•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.

发起方

Viridis BioPharma PvtLtd