Clinical study on Dabur gel in reduction of oral malodor.

Phase 2

Completed

• Conditions: Health Condition 1: R196- Halitosis

• Registration Number: CTRI/2021/07/034750
• Lead Sponsor: Dabur India limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 161

Inclusion Criteria

�Having at least 16 natural, permanent teeth.

�Subjects with bad oral hygiene and halitosis (self-reported or clinically diagnose). Subjects who have plague and dental caries.

�Subjects willing to give their swab samples for analysis.

�Subjects willing to follow 12 hr. overnight gap of brushing/mouthwash and 4 hr. fasting after brushing on day 30 assessment.

�Subjects willing to come for follow up visits at the specified time.

�Subjects ready to follow instructions during the study period.

�Subjects who use oral hygiene products other than Dabur.

�Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.

Exclusion Criteria

�A known history or present condition of hyper sensitivity to any toothpaste.

�The use of antibiotic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.

�Any history of periodontal therapy by surgical interventions.

�Any history of dentine hypersensitivity treatment. Subjects having moderate to severe dentine hypersensitivity.

�Orthodontic treatment with �xed appliances.

�Any removable device such as a removable partial denture or orthodontic retainer.

�The presence of any �xed appliance, large or defective restorations, cracked enamel,

�History of smoking or use of smokeless tobacco products.

�Subjects having moderate to severe dentine hypersensitivity.

�Subjects having abnormal frenum attachment.

�Subjects who are pregnant, lactating or nursing.

�Subjects having severe level of calculus and/ tartar.

�Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�Significant reduction in malodour causing Bacteria by CFU log reduction at various time points in comparison to the baseline and with comparator. <br/ ><br>�Significant reduction in malodour by Oral Chroma assessment at various time points in comparison to the baseline and with comparator. <br/ ><br>�Significant reduction (X%) in oral microflora with product use and with comparator. <br/ ><br>Timepoint: Day 1-T0,Timm, Day30-T0, Timm, T4hr and T12hr

Secondary Outcome Measures

Name	Time	Method
�Significant reduction in plaque, gingivitis, bleeding index and oral hygiene index with regular use of test product at various time points in comparison to the baseline and with comparator. <br/ ><br>Timepoint: Day1-T0,Timm, Day30-T0,Timm