Clinical study to evaluate the Efficacy & Safety of DENTORA�® Gel in the management of Infectious-inflammatory diseases of the the oral cavity.

Not Applicable

Completed

• Conditions: Health Condition 1: K055- Other periodontal diseases

• Registration Number: CTRI/2021/03/031812
• Lead Sponsor: AGIO PHARMACEUTICALS LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-27
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

1.Both males and Females of Age � 6 years to 50, without any known allergy to commercial dental products or cosmetics.

2.Subject who meets with anyone of the following Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity

Exclusion Criteria

1.Subjects who report history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease , chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients.

2.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.

3.Subjects with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.

4.Long-term daily use more than 7 consecutive days of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Evaluation of Tooth sensitivity reduction in Mean Cold Air VAS Stimulus Score using Heft parker Visual Analog Scale <br/ ><br>2. Evaluation of Reduction in gingivitis levels (bleeding on probing) assessed by the Gingival Bleeding Index (GBI)Timepoint: baseline day1 day 5, day 7 and day 10

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of the changes in deep tooth stains from screening to EOT by Lobene Stain index <br/ ><br>2.Evaluation of the changes in tooth mobility for loose tooth roots from screening to EOT by mobility grading <br/ ><br>3.Improvement in overall oral health performance is assessed by Oral Health Assessment Tool for Dental Screening and Oral care Assessment Guide <br/ ><br>4.Incidence and Rate of adverse eventsTimepoint: baseline day1 day 5, day 7 and day 10