A clinical investigation of the extrinsic stain removal efficacy of Colgate total advanced fresh tooth paste as compared to crest regular tooth paste.

Phase 3

Completed

• Conditions: Health Condition 1: R688- Other general symptoms and signsHealth Condition 2: R688- Other general symptoms and signsHealth Condition 3: Y992- Volunteer activityHealth Condition 4: Y992- Volunteer activity

• Registration Number: CTRI/2007/091/000002
• Lead Sponsor: SDM College of Dental sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-05-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Signed Informed Consent Form

2. Good General Health

3. Male and female subjects, aged 18-70, inclusive

4. At least eleven scorable anterior teeth free of large restorations or dental prosthetic crowns.

5. A minimum Lobene Stain Index Area composite score of 25.

6. Available for the entire duration of the study.

7. Clinical evidence of a tendency to form extrinsic stain on anterior teeth.

Exclusion Criteria

1. 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. Five or more carious lesions requiring immediate care.
5. Use of stain inducing medications or oral products up to one month prior to the start of the clinical study.
6. Participation in any other clinical study or panel test or completion of clinical studies in the one month prior to the start of this study.
7. Pregnant or breast feeding women.
8. History of allergies to triclosan. Allergies to dentifrice products, personal care products or their ingredients.
9. Intrinsic stain or restorations on the teeth to be scored which may interfere with the scoring of extrinsic stain.
10. Antibiotic or steroid therapy in the preceding month.
11. Oral prophylaxis in the preceding three months or periodontal treatments in the preceding year.
12. Subjects with grade III calculus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initial stain scores of Lobene Stain Index after four and eight weeks stain scoreTimepoint: 0 week and 8weeks

Secondary Outcome Measures

Name	Time	Method
stain scores of Lobene Stain Index after four and eight weeksTimepoint: 4 and 8 weeks