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Sponsored by: |
Johnson & Johnson Consumer & Personal Products Worldwide |
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Information provided by: | Johnson & Johnson Consumer & Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00174499 |
The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.
Condition | Intervention | Phase |
---|---|---|
Dental Pellicle |
Drug: 2 mg nicotine gum Drug: 4 mg nicotine gum |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | An Open-Label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit |
Enrollment: | 78 |
Study Start Date: | July 2005 |
Study Completion Date: | September 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
2 mg nicotine gum
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Drug: 2 mg nicotine gum
2 mg nicotine gum
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2: Experimental
4 mg nicotine gum
|
Drug: 4 mg nicotine gum
4 mg nicotine gum
|
This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.
The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.
A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | JJCPPW ( Joyce Hauze/Senior Project Manager ) |
Study ID Numbers: | A6431088 |
Study First Received: | September 12, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00174499 History of Changes |
Health Authority: | United States: Institutional Review Board |
Tooth stain |
Nicotine polacrilex Neurotransmitter Agents Nicotine Nicotinic Agonists |
Tooth Discoloration Central Nervous System Stimulants Peripheral Nervous System Agents Cholinergic Agents |
Nicotine polacrilex Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |