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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021007
First Posted: November 26, 2009
Last Update Posted: December 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Colgate Palmolive
  Purpose
Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Condition Intervention Phase
Dental Plaque Drug: Iodine Other: water Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Research Study Efficacy of a Prototype Oral Rinse

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Gingival Index [ Time Frame: 6 weeks ]
  • EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale [ Time Frame: 6 weeks ]
  • Plaque Index (Quigley-Hein Score) [ Time Frame: 6 weeks ]

Enrollment: 67
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
control mouthrinse
Other: water
Use 2 times per day for 6 weeks
Other Name: No actives present in control mouthrinse. (Flavored water)
Experimental: B
new prototype mouthrinse
Drug: Iodine
Rinse 2 times per day for 6 weeks
Other Name: Iocide (proprietary company name)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021007


Locations
United States, New Jersey
New Institutional Service Company
Northfield, New Jersey, United States, 08225
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Matthew Cronin, DMD
  More Information

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01021007     History of Changes
Other Study ID Numbers: CRO-1007-GIN-02-RR
First Submitted: September 26, 2008
First Posted: November 26, 2009
Results First Submitted: September 26, 2008
Results First Posted: November 26, 2009
Last Update Posted: December 1, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases