Status:
COMPLETED
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Participants will be smokers who want to quit, and have visible nicotine stains on their teeth. They will be given toothpaste and a toothbrush to use during the study, and will have an equal chance of...
Detailed Description
This evaluator-blinded, randomized, 12-week parallel-group controlled trial compares Nicorette® Freshmint gum versus Nicorette® Microtab in healthy smokers who are motivated to quit smoking and who ha...
Eligibility Criteria
Inclusion
- Males and females aged 18 to 65 years
- Daily smoker, current daily smoking for at least 1 year
- Motivated to quit smoking, and willing to use NRT (nicotine gum or nicotine sublingual tablet)
- Normal chewing abilities (able to use chewing gum without any problems)
- Willing to refrain from dental prophylaxis for the duration of the 12-week trial
- Have a minimum of 20 natural teeth, with at least 10 of the 12 anterior teeth present and scorable.
- Have a total extrinsic facial tooth stain score equal or more than 28, according to the MacPherson Modification of the Lobene Stain Index.
- Willing and able to comply with scheduled visits, treatment plan, tests, and other trial procedures.
Exclusion
- Use of other tobacco-containing products, such as cigars, pipe, smokeless tobacco products, etc.
- Existing use of any nicotine replacement products for smoking cessation, or undergoing any other treatment for tobacco dependence, such as hypnosis, acupuncture, bupropion, etc.
- Orthodontic appliances
- Gross periodontal disease, or signs of gross oral neglect
- History of oral cancer
- History of temporomandibular joint disorders known to aggravate jaw pain
- Unstable angina pectoris or myocardial infarction during the previous 3 months
- Pregnancy, lactation or intended pregnancy
- Any major metabolic disease, clinically important renal or hepatic disease Suspected alcohol or drug abuse
- Participation in another clinical trial within the previous three months and during study participation
- Any other severe acute or chronic medical or psychiatric condition that might increase the risk associated with trial participation or trial drug administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, makes the subject inappropriate for entry into this trial.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01440985
Start Date
July 1 2005
End Date
November 1 2005
Last Update
July 10 2012
Active Locations (1)
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1
Dental School and Hospital, University College of Cork
Wilton, Cork, Ireland