- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440985
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cork
-
Wilton, Cork, Ireland
- Dental School and Hospital, University College of Cork
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nicotine Gum
After being randomized to the gum or tablet, dosage will be based on baseline level of nicotine dependence.
Highly dependent smokers will receive nicotine 4 mg gum, while low nicotine-dependent smokers will receive nicotine 2 mg gum to help them quit.
Subjects will be advised to use the treatment frequently, according to the product labeling, in order to minimize or avoid symptoms of tobacco withdrawal.
Study medication will be used for 12 weeks.
|
Nicotine Gum 2 mg, Lot number GD922A
Other Names:
Nicotine gum 4 mg, Lot number GC962A
Other Names:
Nicotine Microtab 2 mg, Lot number GB196G
Other Names:
|
Active Comparator: Nicotine Microtab
After being randomized to the gum or tablet, subjects will receive instructions according to their baseline level of nicotine dependence.
Highly dependent smokers will be instructed to use a 4 mg dosage of the Microtab (2 x 2 mg tablets), while low nicotine-dependent smokers will be instructed to use a 2 mg dosage of the Microtab to help them quit.
Subjects will be advised to use the treatment frequently, according to the product labeling, in order to minimize or avoid symptoms of tobacco withdrawal.
Study medication will be used for 12 weeks.
|
Nicotine Gum 2 mg, Lot number GD922A
Other Names:
Nicotine gum 4 mg, Lot number GC962A
Other Names:
Nicotine Microtab 2 mg, Lot number GB196G
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Total Extrinsic Tooth Stain Score
Time Frame: Baseline, 6 Weeks
|
Mean change in total extrinsic tooth stain score, for the whole mouth region.
Extrinsic tooth staining is measured using the MacPherson Modification of the Lobene Stain Index.
A lower stain index score represents a reduction in extrinsic tooth staining.
|
Baseline, 6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Total Extrinsic Tooth Stain Score
Time Frame: Baseline, 2 Weeks
|
Mean change in total extrinsic tooth stain score, for the whole mouth region, measured using the MacPherson Modification of the Lobene Stain Index.
A lower stain index score represents a reduction in extrinsic tooth staining.
|
Baseline, 2 Weeks
|
Change from Baseline in Total Extrinsic Tooth Stain Score
Time Frame: Baseline, 12 Weeks
|
Mean change in total extrinsic tooth stain score, for the whole mouth region, measured using the MacPherson Modification of the Lobene Stain Index.
A lower stain index score represents a reduction in extrinsic tooth staining.
|
Baseline, 12 Weeks
|
Change from Baseline in Mean Stain Index Facial Region
Time Frame: Baseline through Week 12
|
Mean changes in the extrinsic facial surface stain score between baseline and Weeks 2, 6 and 12.
|
Baseline through Week 12
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Change from Baseline in Mean Stain Index Lingual Region
Time Frame: Baseline through Week 12
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Mean changes in the extrinsic lingual surface stain score between baseline and 2, 6 and 12 weeks.
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Baseline through Week 12
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Change from Baseline in Mean Stain Index Body Region
Time Frame: Baseline through Week 12
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Mean changes in the extrinsic body region stain scores between baseline and 2, 6 and 12 weeks.
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Baseline through Week 12
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Change from Baseline in Mean Stain Index Gingival Region
Time Frame: Baseline through Week 12
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Mean changes in the extrinsic gingival region stain scores between baseline and 2, 6 and 12 weeks.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Index Interproximal Region
Time Frame: Baseline through Week 12
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Mean changes in the extrinsic interproximal region stain scores between baseline and 2, 6 and 12 weeks.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Area Total Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region, lingual region, body region, gingival region, and interproximal region (Total Region).
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Area Facial Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region.
|
Baseline through Week 12
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Change from Baseline in Mean Stain Area Lingual Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the lingual region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Area Body Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the body region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Area Gingival Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the gingival region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Area Interproximal Region
Time Frame: Baseline through Week 12
|
Mean stain area between baseline and Weeks 2, 6 and 12 for the interproximal region.
|
Baseline through Week 12
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Change from Baseline in Mean Stain Intensity Total Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region, lingual region, body region, gingival region, and interproximal region (Total Region).
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Intensity Facial Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Intensity Lingual Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the lingual region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Intensity Body Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the body region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Intensity Gingival Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the gingival region.
|
Baseline through Week 12
|
Change from Baseline in Mean Stain Intensity Interproximal Region
Time Frame: Baseline through Week 12
|
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the interproximal region.
|
Baseline through Week 12
|
Change from Baseline in Mean Tooth Shade
Time Frame: Baseline through Week 12
|
Mean tooth shade between baseline and Weeks 2, 6, and 12 using the Vita® Shade Guide.
A higher number represents a lighter tooth shade.
|
Baseline through Week 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- A6431085
- 2005-001040-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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