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

Tobacco Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440985
• Other study ID #: A6431085
• Secondary ID: 2005-001040-23
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: July 6, 2012
• Start date: July 2005
• Est. completion date: November 2005

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine
Nicotine Gum 2 mg, Lot number GD922A
• Nicotine
Nicotine gum 4 mg, Lot number GC962A
• Nicotine
Nicotine Microtab 2 mg, Lot number GB196G

Locations

Country	Name	City	State
Ireland	Dental School and Hospital, University College of Cork	Wilton	Cork

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline in Total Extrinsic Tooth Stain Score	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	No
Secondary	Change from Baseline in Total Extrinsic Tooth Stain Score	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	No
Secondary	Change from Baseline in Mean Stain Index Facial Region	Mean changes in the extrinsic facial surface stain score between baseline and Weeks 2, 6 and 12.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Index Lingual Region	Mean changes in the extrinsic lingual surface stain score between baseline and 2, 6 and 12 weeks.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Index Body Region	Mean changes in the extrinsic body region stain scores between baseline and 2, 6 and 12 weeks.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Index Gingival Region	Mean changes in the extrinsic gingival region stain scores between baseline and 2, 6 and 12 weeks.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Index Interproximal Region	Mean changes in the extrinsic interproximal region stain scores between baseline and 2, 6 and 12 weeks.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Area Total Region	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	No
Secondary	Change from Baseline in Mean Stain Area Facial Region	Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Area Lingual Region	Mean stain area between baseline and Weeks 2, 6 and 12 for the lingual region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Area Body Region	Mean stain area between baseline and Weeks 2, 6 and 12 for the body region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Area Gingival Region	Mean stain area between baseline and Weeks 2, 6 and 12 for the gingival region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Area Interproximal Region	Mean stain area between baseline and Weeks 2, 6 and 12 for the interproximal region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Intensity Total Region	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	No
Secondary	Change from Baseline in Mean Stain Intensity Facial Region	Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Intensity Lingual Region	Mean stain intensity between baseline and Weeks 2, 6 and 12 for the lingual region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Intensity Body Region	Mean stain intensity between baseline and Weeks 2, 6 and 12 for the body region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Intensity Gingival Region	Mean stain intensity between baseline and Weeks 2, 6 and 12 for the gingival region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Stain Intensity Interproximal Region	Mean stain intensity between baseline and Weeks 2, 6 and 12 for the interproximal region.	Baseline through Week 12	No
Secondary	Change from Baseline in Mean Tooth Shade	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	No