A clinical study with herbal toothpaste for plaque control, fresh breath and dental caries reduction

Phase 2/3

Completed

• Conditions: Healthy human volunteers, aged 18-60 years(both genders)with plaque induced gingivitis and caries susceptibility.

• Registration Number: CTRI/2019/08/020921
• Lead Sponsor: Dabur India Limited

Brief Summary

The present clinical study is in 2 parts on samevolunteers with the objectives of:

1.    To study the clinicalefficacy of an herbal dentifrice containing different active ingredients incontrol of plaque induced gingivitis and oral malodor after twice-dailybrushing for a period of 6 weeks.

2.    To evaluate the efficacyof an herbal dentifrice containing different active ingredients forpreventing Dental Caries (same study population); After twice- daily brushingfor a period of 12 months/ 52 weeks.

Overall assessment will be done at the end of 12months.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-19
• Last Update Posted: 2019-08-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Having sound general health 2.
• Not having any known allergy to any of the ingredients of the test product 3.Giving signed consent forms 4.Non pregnant and non lactating females.

Exclusion Criteria

• Those not fulfilling inclusion criteria 2.
• Mouthwash or any other herbal or medicated toothpaste use in recent past 3.having untreated dental caries 4.
• having any orthodontic or prosthetic appliances.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction of Dental plaque, gingivitis and	1. Reduction of Dental plaque, gingivitis and gingival bleeding at 6 weeks. | 2. Reduction in dental caries at 12 months.
gingival bleeding at 6 weeks.	1. Reduction of Dental plaque, gingivitis and gingival bleeding at 6 weeks. | 2. Reduction in dental caries at 12 months.
2. Reduction in dental caries at 12 months.	1. Reduction of Dental plaque, gingivitis and gingival bleeding at 6 weeks. | 2. Reduction in dental caries at 12 months.

Secondary Outcome Measures

Name	Time	Method
Assessment of safety of subjects throughout the study period	End of study

Trial Locations

Locations (1)

Inderprastha Dental College & Hospital, Sahibabad; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

Inderprastha Dental College & Hospital, Sahibabad

🇮🇳Ghaziabad, UTTAR PRADESH, India

Dr Sonia Datta

Principal investigator

9811274799

pankajdatta97@gmail.com