Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Dental Plaque Clinical Trial

Official title:

Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024738
• Other study ID #: CRO-2008-PLA-05-RR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: November 27, 2009
• Start date: March 2008
• Est. completion date: April 2008

Study information

• Verified date: October 2009
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Description:

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Be aged 18 to 65 years inclusive

• Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present

• Give written informed consent

• Be in good general health

• No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study

• If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

• Medical condition which requires pre-medication (antibiotics) prior to dental

• Visits/procedures

• Allergy to chlorhexidine

• Advanced periodontal disease (gum disease)

• 5 or more decayed, untreated dental sites (cavities)

• Diseases of the soft or hard oral tissues (gums or palate)

• Orthodontic appliances that interfere with plaque rating

• Abnormal salivary function

• Use of drugs that can affect currently salivary flow or production

• Use of antibiotics one (1) month prior to or during this study

• Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)

• Pregnant or breastfeeding.

• Participation in another research study in the month preceding this study

• Allergic to common toothpaste or mouth rinse ingredients.

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Fluoride
Brush half mouth twice daily for four days.
• Triclosan, fluoride
Brush twice daily
• Chlorhexidine Gluconate
Rinse mouth twice a day

Locations

Country	Name	City	State
United States	TKL Research, Inc.	Paramus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index		4 Days	No