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

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01021007
First received: September 26, 2008
Last updated: November 27, 2009
Last verified: October 2009

September 26, 2008
November 27, 2009
October 2007
November 2007   (final data collection date for primary outcome measure)
  • Gingival Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plaque Index (Quigley-Hein Score) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021007 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Research Study Efficacy of a Prototype Oral Rinse
Clinical Research Study Efficacy of a Prototype Oral Rinse

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Plaque
  • Drug: Iodine
    Rinse 2 times per day for 6 weeks
    Other Name: Iocide (proprietary company name)
  • Other: water
    Use 2 times per day for 6 weeks
    Other Name: No actives present in control mouthrinse. (Flavored water)
  • Placebo Comparator: A
    control mouthrinse
    Intervention: Other: water
  • Experimental: B
    new prototype mouthrinse
    Intervention: Drug: Iodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021007
CRO-1007-GIN-02-RR
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Matthew Cronin, DMD
Colgate Palmolive
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP