A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining

July 6, 2012 updated by: McNeil AB

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cork
      • Wilton, Cork, Ireland
        • Dental School and Hospital, University College of Cork

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Nicorette® Freshmint Gum
Nicotine gum 4 mg, Lot number GC962A
Other Names:
  • Nicorette® Freshmint Gum
Nicotine Microtab 2 mg, Lot number GB196G
Other Names:
  • Nicorette® Microtab
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:
  • Nicorette® Freshmint Gum
Nicotine gum 4 mg, Lot number GC962A
Other Names:
  • Nicorette® Freshmint Gum
Nicotine Microtab 2 mg, Lot number GB196G
Other Names:
  • Nicorette® Microtab

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
Change from Baseline in Mean Stain Index Lingual Region
Time Frame: Baseline through Week 12
Mean changes in the extrinsic lingual surface stain score between baseline and 2, 6 and 12 weeks.
Baseline through Week 12
Change from Baseline in Mean Stain Index Body Region
Time Frame: Baseline through Week 12
Mean changes in the extrinsic body region stain scores between baseline and 2, 6 and 12 weeks.
Baseline through Week 12
Change from Baseline in Mean Stain Index Gingival Region
Time Frame: Baseline through Week 12
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
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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

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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