Clinical trial on tooth paste

Phase 3

• Registration Number: CTRI/2024/05/067935
• Lead Sponsor: Sriveda Sattva Private Limited Sri Sri Tattva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Subjects were required to be in good general health, between 18 and 65 years of age.

2.Patient willing to offer informed consent and comply with research protocol.

3. Subjects were required to be willing to refrain from using chlorhexidene and or Listerine or any mouth washes which are expected to cause dental staining

4.The subjects were also required to have visible stain on four of the six maxillary anterior teeth and to have at least four of the eight central and lateral incisors with individual Lobene scores greeter than1.5.

5.Presence of extrinsic stains.

6.Atleast 8 of the anterior teeth should be without restoration, no oral prosthesis, no untreated caries

7.Not currently participating in any other clinical trial

Exclusion Criteria

1.Generalized recession of the gingiva (obvious periodontal disease).

2. Generalized malocclusion or overlapping of teeth, anterior teeth caries, severe attrition and abrasion in anterior teeth

3. Inability to comply with brushing instructions (e.g., dexterity or comprehension issues).

4. Pregnant and lactating mothers

5. Person suffering from neurological or psychiatric disorders.

6. Patients suffering from systemic and oral diseases.

7. Individuals with history of present antibiotics and vitamins in form of chewable tablet causing dental staining during use.

9. Patients with history of allergy to herbal drugs, mouth washes, tooth pastes or any other oral hygiene products.

10.Subjects with intrinsic stain in anterior teeth

11. Subjects with a history of consuming tobacco chewing or smoking/chronic betal nut chewing/other regular chewing gums.

12. Individuals already using any form of tooth whitening tooth paste.

13.Participation in clinical pharmacology trial during previous three months.

14.Dental treatment during the period of clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified