Clinical Research Study Efficacy of a Prototype Oral Rinse

Dental Plaque Clinical Trial

— Quigley  

Official title:

Clinical Research Study Efficacy of a Prototype Oral Rinse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021007
• Other study ID #: CRO-1007-GIN-02-RR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: November 27, 2009
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: October 2009
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female volunteers 18-65 years of age

2. Good general health

3. Must sign informed consent form

4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.

5. 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.

6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of = 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

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

4. History of allergy to iodine

5. History of thyroid disease

6. History of diabetes

7. 2 or more decayed untreated dental sites at screening.

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

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

10. Use of medications that are currently affect salivary flow.

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

12. Pregnant or nursing women.

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

14. Use of tobacco products

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

16. Current use of Antibiotics for any purpose.

17. Presence of an orthodontic appliance.

18. History of allergy to common dentifrice ingredients

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

20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).

21. Smoker

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Iodine
Rinse 2 times per day for 6 weeks

Other:
• water
Use 2 times per day for 6 weeks

Locations

Country	Name	City	State
United States	New Institutional Service Company	Northfield	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	Gingival Index		6 weeks	No
Primary	EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale		6 weeks	No
Primary	Plaque Index (Quigley-Hein Score)		6 weeks	No