Clinical trial NCT01440985: A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
Official title: An Evaluator-Blinded, Randomized, Parallel Controlled Study of Nicorette® Freshmint Gum Versus Nicorette® Microtab in Healthy Smokers Motivated to Quit Smoking With Visible Staining of Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Tooth Staining
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 being assigned to use either a nicotine gum or microtab. They will visit the study site five times during the 12 week trial to have their teeth examined.

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 have visible staining of teeth.

The trial is comprised of five visits (baseline, Weeks 1, 2, 6, and 12). At baseline, subjects will be provided with a standardized toothpaste and toothbrush; use of any other oral hygiene or tooth-whitening product is prohibited. At all visits after baseline, smoking status and use of study treatment will be checked. Teeth staining and teeth shade will be rated at baseline and at 2, 6 and 12 Weeks using the Modified Lobene Stain Index and the Vita® Shade Guide, respectively.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Total Extrinsic Tooth Stain Score
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
measure: Change from Baseline in Total Extrinsic Tooth Stain Score
timeFrame: Baseline, 2 Weeks
measure: Change from Baseline in Total Extrinsic Tooth Stain Score
timeFrame: Baseline, 12 Weeks
measure: Change from Baseline in Mean Stain Index Facial Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Index Lingual Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Index Body Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Index Gingival Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Index Interproximal Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Total Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Facial Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Lingual Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Body Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Gingival Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Area Interproximal Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Total Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Facial Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Lingual Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Body Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Gingival Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Stain Intensity Interproximal Region
timeFrame: Baseline through Week 12
measure: Change from Baseline in Mean Tooth Shade
timeFrame: Baseline through Week 12
Other outcomes:
Locations:
city: Wilton
country: Ireland
facility: Dental School and Hospital, University College of Cork
state: Cork
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
citation: Whelton H, Kingston R, O'Mullane D, Nilsson F. Randomized controlled trial to evaluate tooth stain reduction with nicotine replacement gum during a smoking cessation program. BMC Oral Health. 2012 Jun 13;12:13. doi: 10.1186/1472-6831-12-13.