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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01440985
First received: September 23, 2011
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Tobacco Dependence
Drug: Nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Change from Baseline in Total Extrinsic Tooth Stain Score [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in Total Extrinsic Tooth Stain Score [ Time Frame: Baseline, 2 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Total Extrinsic Tooth Stain Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Mean Stain Index Facial Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean changes in the extrinsic facial surface stain score between baseline and Weeks 2, 6 and 12.

  • Change from Baseline in Mean Stain Index Lingual Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean changes in the extrinsic lingual surface stain score between baseline and 2, 6 and 12 weeks.

  • Change from Baseline in Mean Stain Index Body Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean changes in the extrinsic body region stain scores between baseline and 2, 6 and 12 weeks.

  • Change from Baseline in Mean Stain Index Gingival Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean changes in the extrinsic gingival region stain scores between baseline and 2, 6 and 12 weeks.

  • Change from Baseline in Mean Stain Index Interproximal Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean changes in the extrinsic interproximal region stain scores between baseline and 2, 6 and 12 weeks.

  • Change from Baseline in Mean Stain Area Total Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline in Mean Stain Area Facial Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region.

  • Change from Baseline in Mean Stain Area Lingual Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain area between baseline and Weeks 2, 6 and 12 for the lingual region.

  • Change from Baseline in Mean Stain Area Body Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain area between baseline and Weeks 2, 6 and 12 for the body region.

  • Change from Baseline in Mean Stain Area Gingival Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain area between baseline and Weeks 2, 6 and 12 for the gingival region.

  • Change from Baseline in Mean Stain Area Interproximal Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain area between baseline and Weeks 2, 6 and 12 for the interproximal region.

  • Change from Baseline in Mean Stain Intensity Total Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline in Mean Stain Intensity Facial Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region.

  • Change from Baseline in Mean Stain Intensity Lingual Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain intensity between baseline and Weeks 2, 6 and 12 for the lingual region.

  • Change from Baseline in Mean Stain Intensity Body Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain intensity between baseline and Weeks 2, 6 and 12 for the body region.

  • Change from Baseline in Mean Stain Intensity Gingival Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain intensity between baseline and Weeks 2, 6 and 12 for the gingival region.

  • Change from Baseline in Mean Stain Intensity Interproximal Region [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean stain intensity between baseline and Weeks 2, 6 and 12 for the interproximal region.

  • Change from Baseline in Mean Tooth Shade [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    Mean tooth shade between baseline and Weeks 2, 6, and 12 using the Vita® Shade Guide. A higher number represents a lighter tooth shade.


Enrollment: 200
Study Start Date: July 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Nicotine
Nicotine Gum 2 mg, Lot number GD922A
Other Name: Nicorette® Freshmint Gum
Drug: Nicotine
Nicotine gum 4 mg, Lot number GC962A
Other Name: Nicorette® Freshmint Gum
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.
Drug: Nicotine
Nicotine Microtab 2 mg, Lot number GB196G
Other Name: Nicorette® Microtab

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440985

Locations
Ireland
Dental School and Hospital, University College of Cork
Wilton, Cork, Ireland
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided by Johnson & Johnson Consumer and Personal Products Worldwide

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01440985     History of Changes
Other Study ID Numbers: A6431085, 2005-001040-23
Study First Received: September 23, 2011
Last Updated: July 6, 2012
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Tooth Staining

Additional relevant MeSH terms:
Nicotine
Sodium Fluoride
Listerine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014