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

NCT01024738 | Completed Phase 3 Results

• 1 other identifier: CRO-2008-PLA-05-RR
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Plaque Index

  Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

  4 Days

Study Arms (3)

Fluoride toothpaste

PLACEBO COMPARATOR

negative control toothpaste

Drug: Fluoride

Triclosan/Fluoride toothpaste

ACTIVE COMPARATOR

positive control toothpaste (Total toothpaste)

Drug: Triclosan, fluoride

Chlorhexidine Oral Rinse

ACTIVE COMPARATOR

positive control oral rinse

Drug: Chlorhexidine Gluconate

Interventions

Fluoride DRUG

Brush half mouth twice daily for four days.

Fluoride toothpaste

Triclosan, fluoride DRUG

Brush twice daily

Also known as: Total toothpaste

Triclosan/Fluoride toothpaste

Chlorhexidine Gluconate DRUG

Rinse mouth twice a day

Chlorhexidine Oral Rinse

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Medical condition which requires pre-medication (antibiotics) prior to dental
• Visits/procedures
• Allergy to chlorhexidine
• Advanced periodontal disease (gum disease)
• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

TKL Research, Inc.

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William DeVizio - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Mark LeFelt, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: December 3, 2009
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 3, 2009
• Results First Posted: December 3, 2009

Record last verified: 2009-10

Locations

US (1)