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

Prospective, Single-Centre, Non-Randomized, Open-Label, Single-Arm, Post Marketing Study to Evaluate Safety and Efficacy of DENTE91�® Mom Toothpaste and DENTE91�® Mom Mouthwash in Pregnant Females - Dente 91 Mom

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044117
Enrollment
30
Registered
2022-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K051- Chronic gingivitis

Interventions

Intervention1: DENTE91�® Mom Mouthwash: DENTE91�® Mom Mouthwash 5 ml twice daily for 60 days Intervention2: DENTE91�® Mom Toothpaste: DENTE91�® Mom Toothpaste 5 ml twice daily for 60 days Cont

Sponsors

Dr Faiza Tekrawala
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Evaluate antimicrobial effectivenessTimepoint: Day 60

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Faiza Tekrawala

Dr. Faizas Dental Clinic

sanaaz2931@gmail.com7925352277

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026