Tobacco DependenceNCT01440985
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
A study testing Nicotine in people with Tobacco Dependence, run by McNeil AB at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2005to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Dental School and Hospital, University College of Cork
Wilton, Cork
About this study
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
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.
Read the 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
- Being tested
- Nicotine
- Keywords
- Tooth Staining
- Medical subject headings
- Tobacco Use Disorder, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Nicorette® Freshmint Gum
Nicotine Gum 2 mg, Lot number GD922A
NicotineDrug
Also called Nicorette® Freshmint Gum
Nicotine gum 4 mg, Lot number GC962A
NicotineDrug
Also called Nicorette® Microtab
Nicotine Microtab 2 mg, Lot number GB196G
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Weeks
Secondary outcomes (20)
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.
Measured: Baseline, 2 Weeks
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.
Measured: Baseline, 12 Weeks
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.
Measured: Baseline through Week 12
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.
Measured: Baseline through Week 12
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.
Measured: Baseline through Week 12
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.
Measured: Baseline through Week 12
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.
Measured: Baseline through Week 12
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).
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Area Facial Region
Mean stain area between baseline and Weeks 2, 6 and 12 for the facial region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Area Lingual Region
Mean stain area between baseline and Weeks 2, 6 and 12 for the lingual region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Area Body Region
Mean stain area between baseline and Weeks 2, 6 and 12 for the body region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Area Gingival Region
Mean stain area between baseline and Weeks 2, 6 and 12 for the gingival region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Area Interproximal Region
Mean stain area between baseline and Weeks 2, 6 and 12 for the interproximal region.
Measured: Baseline through Week 12
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).
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Facial Region
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the facial region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Lingual Region
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the lingual region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Body Region
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the body region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Gingival Region
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the gingival region.
Measured: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Interproximal Region
Mean stain intensity between baseline and Weeks 2, 6 and 12 for the interproximal region.
Measured: Baseline through Week 12
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.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startJul 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440985
- Sponsor's protocol ID
- A6431085
- Other IDs
- 2005-001040-23, 2005
- Status last verified
- Jul 2012
- First submitted
- 23 Sep 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22695211
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01440985
- Acronym / sponsor ID
- A6431085
- Conditions
- Tobacco Dependence
- Keywords
- Tooth Staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Gum | Experimental | Drug: NicotineAfter 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 Microtab | Active comparator | Drug: NicotineAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: Nicorette® Freshmint GumNicotine Gum 2 mg, Lot number GD922A | Drug | Nicotine Gum |
| NicotineAlso: Nicorette® Freshmint GumNicotine gum 4 mg, Lot number GC962A | Drug | Nicotine Gum |
| NicotineAlso: Nicorette® MicrotabNicotine Microtab 2 mg, Lot number GB196G | Drug | Nicotine Microtab |
Primary outcome
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.
20 secondary outcomes
Change from Baseline in Total Extrinsic Tooth Stain Score
Time frame: Baseline, 2 Weeks
Change from Baseline in Total Extrinsic Tooth Stain Score
Time frame: Baseline, 12 Weeks
Change from Baseline in Mean Stain Index Facial Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Index Lingual Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Index Body Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Index Gingival Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Index Interproximal Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Total Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Facial Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Lingual Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Body Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Gingival Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Area Interproximal Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Total Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Facial Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Lingual Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Body Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Gingival Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Stain Intensity Interproximal Region
Time frame: Baseline through Week 12
Change from Baseline in Mean Tooth Shade
Time frame: Baseline through Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 22695211Whelton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine in people with Tobacco Dependence, run by McNeil AB at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Extrinsic Tooth Stain Score (time frame: Baseline, 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01440985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.