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Trial record 9 of 1955 for:    Smoking: Clinical Trials
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A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
NYU College of Dentistry
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591175
First received: December 26, 2007
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

The goal of this study is to see if giving patients information about how smoking affects oral health will help them quit smoking. What we learn from this study will help researchers find new ways to help smokers.


Condition Intervention
Smoking Cessation
 Behavioral: Standard Care only
Behavioral: Dental Hygienist provided counseling + Brief Questionnaire
Behavioral: Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • efficacy of varied smoking cessation interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Salvia


Enrollment: 1072
Study Start Date: December 2001
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Standard Care
 Behavioral: Standard Care only
Dentist Provided Standard Care, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test
2
Standard Care with Hygienist Counseling
 Behavioral: Dental Hygienist provided counseling + Brief Questionnaire
Dental Hygienist provided + Brief Questionnaire, 3-month follow-up assessment,Clinic visit salivary cotinine test, 12-month follow-up, Clinic visit salivary cotinine test assessment
3
Standard Care with Hygienist Counseling & Personalized Risk Communication
 Behavioral: Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire
Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Smokers who are also patients at the NYU College of Dentistry

Criteria

Inclusion Criteria:

  • Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care
  • Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day)
  • Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months
  • Fluent in English or Spanish

Exclusion Criteria:

  • History of mouth or throat cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591175

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
NYU College of Dentistry
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00591175     History of Changes
Obsolete Identifiers: NCT00070798
Other Study ID Numbers: 01-117
Study First Received: December 26, 2007
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 21, 2013