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

NCT01440985 | Completed

• 2 other identifiers: A64310852005-001040-23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence

Keywords

Tooth Staining

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Extrinsic Tooth Stain Score

  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 Outcomes (20)

• Change from Baseline in Total Extrinsic Tooth Stain Score

  Baseline, 2 Weeks

• Change from Baseline in Total Extrinsic Tooth Stain Score

  Baseline, 12 Weeks

• Change from Baseline in Mean Stain Index Facial Region

  Baseline through Week 12

• Change from Baseline in Mean Stain Index Lingual Region

  Baseline through Week 12

• Change from Baseline in Mean Stain Index Body Region

  Baseline through Week 12

Study Arms (2)

Nicotine Gum

EXPERIMENTAL

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 Microtab

ACTIVE COMPARATOR

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

Interventions

Nicotine DRUG

Nicotine Gum 2 mg, Lot number GD922A

Also known as: Nicorette® Freshmint Gum

Nicotine Gum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Dental School and Hospital, University College of Cork

Wilton, Cork, Ireland

Location

Related Publications (1)

• 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.

  PMID: 22695211 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Tooth Discoloration

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: July 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

IE (1)