Dente 91 Mom Toothpaste and Mouthwash study on dental health of pregnant females.

Not Applicable

Completed

• Conditions: Health Condition 1: K051- Chronic gingivitis

• Registration Number: CTRI/2022/07/044117
• Lead Sponsor: Dr Faiza Tekrawala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-02
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Pregnant female subjects aged 20 years onwards with positive urine pregnancy tests/serum pregnancy tests

Willingness to provide written informed consent and comply with study instructions for its duration

Subjects having extrinsic dental stains and bad oral hygiene

Subjects having one or more dental cavities

Subjects with history of dental caries/tooth decay

At least one sensitive teeth (buccal/facial aspect with recession, abrasion, erosion) with a score of more than 3 cm using air blast on the Visual Analogue Scale

Exclusion Criteria

Known hypersensitivity to any tooth paste

Use of any antibioitic, antimicrobial, analgesic medications, mouthwash or desensitizing toothpaste 1 month prior to screening

Any history of periodontal therapy by surgical interventions

Any history of dentine hypersensitivity treatment

Any orthodontic treatment with fixed appliances

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

Presence of any fixed appliance, large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth

Subjects having intrinsic dental stains

Subjects having abnormal frenum attachment

Subjects having severe level of calculus and tartar

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate antimicrobial effectivenessTimepoint: Day 60

Secondary Outcome Measures

Name	Time	Method
evaluate healing of dental cavitiesTimepoint: Day 60;evaluate prophylaxis of nausea and vomitingTimepoint: Day 60;evaluate protection against dental caries / tooth decayTimepoint: Day 60;Evaluate reduction in hypersensitivityTimepoint: Day 60;evaluate reduction of stainsTimepoint: Day 60;evaluate safetyTimepoint: Day 60