Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Sponsorit

Johtava sponsori: Colgate Palmolive

Lähde Colgate Palmolive
Lyhyt yhteenveto

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Yleinen tila Completed
Aloituspäivämäärä 2007-10-01
Valmistumispäivä 2008-01-01
Ensisijainen valmistumispäivä 2008-01-01
Vaihe Phase 3
Tutkimuksen tyyppi Interventional
Ensisijainen tulos
Mitata Aikaikkuna
Plaque Index 8 weeks
Ilmoittautuminen 25
Kunto
Interventio

Interventiotyyppi: Drug

Intervention nimi: Fluoride

Kuvaus: Brush twice daily

Varren ryhmän etiketti: Fluoride Toothpaste

Interventiotyyppi: Drug

Intervention nimi: Triclosan/Fluoride toothpaste

Kuvaus: Brush twice daily

Varren ryhmän etiketti: Total/Whitening

Interventiotyyppi: Drug

Intervention nimi: Fluoride

Kuvaus: Brush twice daily

Varren ryhmän etiketti: antibacterial plant extract 1

Muu nimi: honokiol

Interventiotyyppi: Drug

Intervention nimi: Fluoride

Kuvaus: Brush twice daily

Varren ryhmän etiketti: antibacterial plant extract 2

Interventiotyyppi: Other

Intervention nimi: antibacterial plant extract

Kuvaus: Brush twice daily

Varren ryhmän etiketti: antibacterial plant extract 2

Muu nimi: Honokiol

Tukikelpoisuus

Kriteeri:

Inclusion Criteria: - Male or female volunteers 18-65 years of age. - Good general health. - Must sign informed consent form. - Must discontinue oral hygiene on the mornings of each appointment and between sampling periods. - 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. Exclusion Criteria: - Medical condition which requires pre-medication prior to dental procedures/visits. - Medical condition which precludes eating/drinking for 12 hrs. - History of allergy to common dentifrice ingredients. - Subjects unable or unwilling to sign the informed consent form. - Moderate or advanced periodontal disease. - Two 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 currently affect salivary flow. - Current use of antibiotics. - 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 30 days 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. - Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).

Sukupuoli:

All

Vähimmäisikä:

18 Years

Enimmäisikä:

65 Years

Terveet vapaaehtoiset:

Accepts Healthy Volunteers

Kaiken virallinen
Sukunimi Rooli
Yanfang Ren, DDS Principal Investigator
Sijainti
Laitos: Eastman Dental Center - University of Rochester
Sijainti Maat

United States

Vahvistuspäivä

2009-09-01

Vastuullinen osapuoli

Nimi Otsikko: William DeVizio/VP - Clinical Research

Organisaatio: Colgate Palmolive

On laajentanut käyttöoikeuksia No
Ehto Selaa
Aseiden lukumäärä 4
Arm-ryhmä

Tarra: Fluoride Toothpaste

Tyyppi: Placebo Comparator

Kuvaus: fluoride control

Tarra: Total/Whitening

Tyyppi: Active Comparator

Kuvaus: positive control

Tarra: antibacterial plant extract 1

Tyyppi: Experimental

Kuvaus: Honokiol

Tarra: antibacterial plant extract 2

Tyyppi: Experimental

Kuvaus: magnolol

Tutkimuksen suunnittelutiedot

Jakaminen: Randomized

Interventiomalli: Crossover Assignment

Päätarkoitus: Treatment

Naamiointi: Double (Participant, Investigator)

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