Compare the Clinical Efficacy of Prototype Toothpastes

NCT00926029 | Completed Phase 3 Results

• 1 other identifier: CRO-2007-GIN-06-RR
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (2)

• Plaque Index

  Plaque Index score 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)

  6 weeks

• Gingivitis Index

  Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  6 Weeks

Study Arms (3)

Fluoride control -A

PLACEBO COMPARATOR

Winterfresh Gel

Drug: Fluoride

Triclosan/Fluoride - B

ACTIVE COMPARATOR

Positive control (Total toothpaste)

Drug: Triclosan, fluoride

Triclosan/fluoride/metal salt- C

EXPERIMENTAL

test toothpaste

Other: Metal salt

Interventions

Fluoride DRUG

Brush twice daily

Also known as: Colgate Winterfresh Gel

Fluoride control -A

Triclosan, fluoride DRUG

Brush twice daily

Also known as: Colgate Total toothpaste

Triclosan/Fluoride - B

Metal salt OTHER

Brush twice daily

Also known as: New toothpaste formula being evaluated.

Triclosan/fluoride/metal salt- C

Eligibility Criteria

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

You may qualify if:

• Male or female volunteers 18-65 years of age.
• Good general health.
• Must sign informed consent form.
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
• 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.

You may not qualify if:

• Subject unable or unwilling to sign the informed consent form.
• Medical condition which requires pre-medication prior to dental visits/procedures.
• Moderate or advanced periodontal disease.
• or more decayed untreated dental sites at screening.
• Other disease of the hard or soft oral tissues.
• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
• Use of medications that currently affect salivary flow.
• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
• Pregnant or nursing women.
• Participation in any other clinical study within 1 week prior to enrollment into this study.
• Use of tobacco products.
• Subjects who must receive dental treatment during the study dates.
• Current use of Antibiotics for any purpose.
• Presence of an orthodontic appliance.
• History of allergy to common dentifrice ingredients.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Concordia Clinical Research

Cedar Knolls, New Jersey, 07927, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorides; Colgate Winterfresh Fluoride Gel; Triclosan; hydrated silica gel-based toothpaste; ZIF-8 metal-organic framework

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

• Salim A Nathoo, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: June 23, 2009
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 17, 2012
• Results First Posted: June 23, 2009

Record last verified: 2011-06

Locations

US (1)