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

A randomized double-blind parallel clinical trial to compare the stain removal efficacy of Colgate total advanced fresh tooth paste and crest regular tooth paste on extrinsic stains on the teeth.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2007/091/000002

Enrollment

120

Registered

2007-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R688- Other general symptoms and signs Health Condition 2: R688- Other general symptoms and signs Health Condition 3: Y992- Volunteer activity Health Condition 4: Y992- Volunteer activity

Interventions

Intervention1: stain removal -silica: topical application,twice dailly for 8 weeks Control Intervention1: sodium Flouride: topical application,twice dailly for 8 weeks

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Initial stain scores of Lobene Stain Index after four and eight weeks stain scoreTimepoint: 0 week and 8weeks	—

Secondary

Measure	Time frame
stain scores of Lobene Stain Index after four and eight weeksTimepoint: 4 and 8 weeks	—

Countries

India

Contacts

Public ContactDr C Bhasker Rao

baskerrao@hotmail.com08362467676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026