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A Study to Test the Safety and Effectiveness of Mintdrops Toothpaste Tablets for Better Oral Health.

An Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Safety, Tolerability, And Efficacy Of Mintdrops Toothpaste Tablets In Improvement Of Oral Hygiene - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074299
Enrollment
130
Registered
2024-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

None listed

Sponsors

Giosun Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and Female patients aged 13 to 70 years. 2.Willing to voluntarily sign a written informed consent. 3.At least 24 scorable teeth free of large restorations or dental prosthetic crowns. 4.In good general health. 5.Available for the entire duration of the study. 6.Clinical evidence of a tendency to form plaque on teeth.

Exclusion criteria

Exclusion criteria: 1.Presence of orthodontic appliances or more than one incisor with a prosthetic crown or veneer. 2.Tumors or significant pathology of the soft or hard tissues of the oral cavity. 3.Moderate or advanced periodontal disease 4.Participation in any other clinical study or panel test in the month prior to the start of this study. 5.Pregnant or breastfeeding women. 6.Antibiotic or steroid therapy in the preceding month.

Design outcomes

Primary

MeasureTime frame
Reduction in Dental Plaque Assessed using the Plaque Index (PI) or the Modified Quigley-Hein Plaque Index (MQHPI) from baseline to the end of the studyTimepoint: Day 1, Day 10, Day 20, Day 30

Secondary

MeasureTime frame
1.Improvement in Self-Reported Oral Hygiene Practices: Evaluated through questionnaires or surveys administered at baseline and at the end of the study. 2.Reduction in Gingival Inflammation: Measured using the Gingival Index (GI) from baseline to the end of the study. 3.Adverse Events Monitoring: Recording and evaluating any adverse events reported during the study period to assess the safety of Mintdrops Toothpaste TabletsTimepoint: Day 1, Day 10, Day 20, Day 30

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results

None listed

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