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

Completed

• Conditions: Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity; Other periodontal diseases,

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

Brief Summary

A prospective, Interventional, Randomized, parallel, active-controlled comparative clinical study to evaluate the Efficacy & Safety of DENTORA® Gel in the management of Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity.

The DENTORA® Gel is used to treat   Infectious-inflammatory diseases of the parodontium and mucosa. 

Treatment duration will be total 10 days  (7 Days treatments and follow up on 10 th  Days)

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|Study will be conducted on 80  subjects in 2 arm

Arm-I: – 40 Subjects-DENTORA®GEL

Arm-II:– 40 Subjects- Metrogyl Denta

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Study Completion: 2021-11-27
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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	baseline day1 day 5, day 7 and day 10
2. Evaluation of Reduction in gingivitis levels (bleeding on probing) assessed by the Gingival Bleeding Index (GBI)	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	2.Evaluation of the changes in tooth mobility for loose tooth roots from screening to EOT by mobility grading

Trial Locations

Locations (3)

M. V. Hospital and research centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Mysore medical college and research Institute.; 🇮🇳 Mysore, KARNATAKA, India

Santosh Hospital; 🇮🇳 Bangalore, KARNATAKA, India

M. V. Hospital and research centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr shashank

Principal investigator

7007208089

drs.tiwari@yahoo.in