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Clinical Research Study Efficacy of a Prototype Oral Rinse

NCT ID: NCT01021007

Last Updated: 2009-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

control mouthrinse

Group Type PLACEBO_COMPARATOR

water

Intervention Type OTHER

Use 2 times per day for 6 weeks

B

new prototype mouthrinse

Group Type EXPERIMENTAL

Iodine

Intervention Type DRUG

Rinse 2 times per day for 6 weeks

Interventions

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Iodine

Rinse 2 times per day for 6 weeks

Intervention Type DRUG

water

Use 2 times per day for 6 weeks

Intervention Type OTHER

Other Intervention Names

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Iocide (proprietary company name) No actives present in control mouthrinse. (Flavored water)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Colgate Palmolive

Principal Investigators

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Matthew Cronin, DMD

Role: PRINCIPAL_INVESTIGATOR

Locations

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New Institutional Service Company

Northfield, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-1007-GIN-02-RR

Identifier Type: -

Identifier Source: org_study_id