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

NCT ID: NCT01440985

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2005-11-30

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.

Conditions

Tobacco Dependence

Keywords

Tooth Staining

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

Nicotine Gum 2 mg, Lot number GD922A

Nicotine

Intervention Type: DRUG

Nicotine gum 4 mg, Lot number GC962A

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.

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

Nicotine Microtab 2 mg, Lot number GB196G

Interventions

Nicotine

Nicotine Gum 2 mg, Lot number GD922A

Intervention Type: DRUG

Nicotine

Nicotine gum 4 mg, Lot number GC962A

Intervention Type: DRUG

Nicotine

Nicotine Microtab 2 mg, Lot number GB196G

Intervention Type: DRUG

Other Intervention Names

Nicorette® Freshmint Gum; Nicorette® Freshmint Gum; Nicorette® Microtab

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McNeil AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Dental School and Hospital, University College of Cork

Wilton, Cork, Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 22695211 (View on PubMed)

Other Identifiers

2005-001040-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A6431085

Identifier Type: -

Identifier Source: org_study_id