Training and Calibration of Dental Examiners

Dental Plaque Clinical Trial

Official title:

Training and Calibration of Dental Examiners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765167
• Other study ID #: ATO-2007-PLA-01-RR
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: October 2, 2008
• Start date: November 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Training and calibration of dental examiners

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female volunteers 18-65 years of age

• Good general health

• Must sign informed consent form

• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

• No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.

2. Medical condition which requires pre-medication prior to dental visits/procedures

3. Moderate or advanced periodontal disease or heavy dental tartar (calculus).

4. 2 or more decayed untreated dental sites at screening.

5. Other disease of the hard or soft oral tissues.

6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).

8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

9. Pregnant or nursing women.

10. Participation in any other clinical study within 1 week prior to enrollment into this study.

11. Allergy to chlorhexidine

12. Use of tobacco products

13. Subjects who must receive dental treatment during the study dates.

14. Current use of Antibiotics for any purpose.

15. Presence of an orthodontic appliance.

16. History of allergy to common dentifrice ingredients.

17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Fluoride
Brush half mouth twice daily for four days
• Triclosan
Brush half mouth daily for four days
• Chlorhexidine gluconate
Mouth rinsing with 15 ml for 30 seconds twice a day for four days
• Fluoride
Brush half mouth daily for four days

Locations

Country	Name	City	State
United States	UMDNJ Dental School	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental plaque		6 weeks	No