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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Research Study Efficacy of a Prototype Oral Rinse

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: November 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014