Clinical study on Toothpastes for toothache, dental caries and oral hygiene

Phase 2

Completed

• Conditions: Health Condition 1: K029- Dental caries, unspecifiedHealth Condition 2: K039- Disease of hard tissues of teeth,unspecified

• Registration Number: CTRI/2014/11/005212
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

•Subjects with age group 12-65 years in general good health and oral health.

•Subjects should have at least one tooth from which a painful response could be elicited by both a dental explorer and air blast.

•Subjects having ICADS score of less than 2 concerning dental caries.

•Subjects having extrinsic dental stains and bad oral hygiene.

•Subjects willing to give a voluntary written informed consent for photography release and agree to come for regular follow up.

•Subjects willing to abide by and comply with the study protocol.

•Subjects who have not participated in a similar investigation in the past four weeks.

•Subjects who will be available for the entire duration of the study.

•Subjects who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria

•A known history or present condition of hyper sensitivity to any tooth paste.

•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.

•Orthodontic treatment with ï¬?xed appliances.

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

•The presence of any ï¬?xed appliance, large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth.

•History of smoking or smokeless tobacco products.

•Subjects having intrinsic dental stains.

•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
ï?¶ Reduction of toothache in relation to hypersensitivity in comparison to baseline. <br/ ><br>ï?¶ Optimum protection of dental caries in comparison to baseline.Timepoint: 5 visits <br/ ><br>Visit 1 (Screening), Visit 2 (baseline), Visit 3 (Week 4), Visit 4 (Week 12) & Visit 5 (Week 24).