Training and Calibration of Dental Examiners

NCT00765167 | Completed Phase 3

• 1 other identifier: ATO-2007-PLA-01-RR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Training and calibration of dental examiners

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Dental plaque

  6 weeks

Study Arms (3)

A

PLACEBO COMPARATOR

Drug: Fluoride

B

ACTIVE COMPARATOR

Drug: Triclosan; Drug: Fluoride

C

ACTIVE COMPARATOR

Drug: Chlorhexidine gluconate

Interventions

Fluoride DRUG

Brush half mouth twice daily for four days

A

Triclosan DRUG

Brush half mouth daily for four days

B

Chlorhexidine gluconate DRUG

Mouth rinsing with 15 ml for 30 seconds twice a day for four days

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:

• Subjects 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 heavy dental tartar (calculus).
• 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 can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
• 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.
• Allergy to chlorhexidine
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

UMDNJ Dental School

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorides; Triclosan; 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

Study Officials

• Michael Deasy, DDS

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: October 2, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 3, 2008

Record last verified: 2008-10

Locations

US (1)