A Clinical Trial to assess the Efficacy and Safety of Ayurvedic Dant Manja

Phase 4

Completed

• Conditions: Health Condition 1: null- Gingivitis,Dental Plaque,Teeth Stains,Bad Oral Breath,Teeth Sensitivity

• Registration Number: CTRI/2018/01/011253
• Lead Sponsor: Manisha Sales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1)Men and women (age 18-60 years) who are suffering with dental health problems

2)At least 20 natural teeth suitable for evaluation

3)Subjects having gingivitis with gingival index > 1

4)Subjects having dental plaque with plaque index of 2 or more

5)Able and willing to sign approved informed consent

Exclusion Criteria

1)Females disagree to birth control measure for the duration of the study

2)Known allergy to constituents of the formulation of toothpowder.

3)Subjects with preexisting systemic diseases necessitating long term medications

4)Subjects having advanced Dental disease

5)Subjects having diseases of soft /hard tissues

6)Subjects Having fixed orthodontic appliances (including permanent orthodontic retainers)

7)Subjects with Abnormal salivary function

8)Having any acute /chronic systemic illness

9)Subjects who have the habit of consuming alcohol, smoking, chewing gums, pan or gutka.

10)Pregnant or lactating Females

11)Antibiotic use in the last 3 months

12)Routine use of anticoagulant medication

13)Routine use of anti-inflammatory medication

14)Routine use of medications known to have effects on the gingiva (e.g., phenytoin etc)

15)Routine use of medications inhibiting or stimulating salivary flow

16)Physical handicap that could interfere with daily performance of oral hygiene

17)Participation in any other study during the study period of this trial

18)Routine use of any mouthrinse

19)Routine use of any interdental cleaning device (floss, dental toothpicks)

20)Having probing depth >=4 mm at any site

21)Having had active periodontal therapy during the last 6 months

22)Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months

23)More than 3 carious lesions requiring immediate care

24)Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)

Study & Design

• Study Type: PMS
• Study Design: Not specified