Clinical Research Study Efficacy of a Prototype Oral Rinse (Quigley)

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque

Treatments: Other: water; Drug: Iodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021007

CRO-1007-GIN-02-RR

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

control mouthrinse

Treatment:

Other: water

B

Experimental group

Description:

new prototype mouthrinse

Treatment:

Drug: Iodine