Randomozed,Blinded, placebo controlled, clinical study to evaluate the efficacy of Dabur Babool Neem Toothpaste DRDC/PC/8003 in oral hygeine and dental care

Not Applicable

Completed

• Conditions: Health Condition 1: K051- Chronic gingivitisHealth Condition 2: K053- Chronic periodontitis

• Registration Number: CTRI/2016/12/007529
• Lead Sponsor: Dabur India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Periodontitis & Gingival Group:

1. Subjects of both sexes in the age groups of 18-45 yrs

2. Subjects willing to sign informed consent form

3. Subjects who have at least 20 natural uncrowned teeth excluding third molars.

4. Subjects with periodontitis and gingivitis

5. Subjects with ability to comply with all study requirements.

6. Subjects having gingivitis with gingival index > 1 at more than 60 % of sites examined.

7. Subjects with tooth stains.

8. Subjects having dental plaque with plaque index of 2 or more.

Healthy Group:

1. Healthy subjects of both sexes in the age group of 18 to 45 years.

2. Subjects willing to sign informed consent form.

3. Subjects who have at least 20 natural uncrowned teeth excluding third molars.

4. Subjects with ability to comply with all study requirements.

Exclusion Criteria

Periodontitis & Gingival Group:

1. Subjects having pain and multiplicity of periodontal/gingival problems or advanced generalized chronic inflammatory periodontal disease or any gross oral pathology.

2. Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.

3. Subjects having any serious systemic disease.

4. Subjects with any external dental treatment like scaling, polishing, flossing etc.

5. Subjects with Upper respiratory tract infection, Urinary tract infection, Gastrointestinal Tract infection, Skin infection.

6. Subjects with history of intake of antibiotics and anti-inflammatory drugs for the past 3-4 weeks

7. Subjects with history of fluoride treatment for the past two weeks.

8. Pregnant or lactating mothers.

9. Subjects with involvement in any concurrent study the nature of which may affect the parameters being investigated in the study.

10. Subjects not willing to sign informed consent.

11. Subjects not willing to come for follow-up when required

12. Subjects with presence of relatively severe tetracycline stained teeth.

Healthy Group:

As per the exclusion criteria for gingivitis & periodontitis group.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For GIngivitis & Periodontitis Group: <br/ ><br>change in scores of gingivitis &/or signs & symptoms, change in microbiologiacl assesment (swab culture), elimination/reduction in malodor if applicable, change in scores of lobene stain &/or signs & symptoms, change in plaque scores &/or signs & symptoms, change in clinivcal attachement loss <br/ ><br>For Healthy Group: <br/ ><br>Reduction in microbial counts (swab culture)Timepoint: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group

Secondary Outcome Measures

Name	Time	Method
For GIngivitis & Periodontitis Group: <br/ ><br>Global patient & Investigator evaluation, ADR/AE profile <br/ ><br>For Healthy Group: <br/ ><br>Lobene index, organoleptic index, plaque assesment/plaque index, gingival index, clinical attachment loss, ADR/AE profileTimepoint: 12 weeks for gingivits & periodontitis group & 6 weeks for healthy group <br/ ><br>