Dental PelliclePhase 4NCT00174499
A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum
A Phase 4 study testing 2 mg nicotine gum and 4 mg nicotine gum in people with Dental Pellicle, run by McNeil AB.
Trial summary
The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Pellicle
- What is being tested?
- 2 mg nicotine gum and 4 mg nicotine gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Sep 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- daily smokers for at least one year
- motivated to quit smoking
- normal chewing ability
- willing to refrain from a dental prophylaxis for the duration of the study
- total extrinsic facial tooth stain score > or = to 28, according to the MacPherson Modification of the Lobene Stain Index
Who cannot join
- < 20 natural teeth
- inadequate oral hygiene
About this study
Official title: An Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit
The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.
Read the detailed description
This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.
The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.
A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.
- Conditions
- Dental Pellicle
- Being tested
- 2 mg nicotine gum, 4 mg nicotine gum
- Keywords
- Tooth stain
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg nicotine gumDrug
Also called Nicorette Fresh Mint
2 mg nicotine gum
4 mg nicotine gumDrug
Also called Nicorette Fresh Mint
4 mg nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 mg nicotine gum Receives: Drug: 2 mg nicotine gum |
| 2 | Experimental | 4 mg nicotine gum Receives: Drug: 4 mg nicotine gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to assess, by using the MacPherson modification of the Lobene Stain Index, the amount of extrinsic tooth-stain reduction from Baseline while quitting smoking using Nicorette Freshmint gum
Measured: 6 Weeks
Secondary outcomes (3)
To assess reduction in tooth-staining in relation to usage of gums
Measured: 6 Weeks
To assess smoking status
Measured: 6 Weeks
To assess safety
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PellicleStudies 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 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth A Kruse, PhD, Study director, JJCPPW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174499
- Sponsor's protocol ID
- A6431088
- Status last verified
- Jul 2012
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
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 Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit
- ClinicalTrials.gov ID
- NCT00174499
- Acronym / sponsor ID
- A6431088
- Conditions
- Dental Pellicle
- Keywords
- Tooth stain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.
Detailed description
This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.
The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.
A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 2 mg nicotine gum2 mg nicotine gum |
| 2 | Experimental | Drug: 4 mg nicotine gum4 mg nicotine gum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- daily smokers for at least one year
- motivated to quit smoking
- normal chewing ability
- willing to refrain from a dental prophylaxis for the duration of the study
- total extrinsic facial tooth stain score > or = to 28, according to the MacPherson Modification of the Lobene Stain Index
Key exclusion criteria (2 listed)
- < 20 natural teeth
- inadequate oral hygiene
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 |
|---|---|---|
| 2 mg nicotine gumAlso: Nicorette Fresh Mint2 mg nicotine gum | Drug | 1 |
| 4 mg nicotine gumAlso: Nicorette Fresh Mint4 mg nicotine gum | Drug | 2 |
Primary outcome
The primary objective of this study was to assess, by using the MacPherson modification of the Lobene Stain Index, the amount of extrinsic tooth-stain reduction from Baseline while quitting smoking using Nicorette Freshmint gum
Time frame: 6 Weeks
3 secondary outcomes
To assess reduction in tooth-staining in relation to usage of gums
Time frame: 6 Weeks
To assess smoking status
Time frame: 6 Weeks
To assess safety
Time frame: 6 Weeks
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.
Related trials for Dental Pellicle
Recruiting
PMPR and Chlorhexidine on Periodontal Disease and Vascular Function
Periodontal Disease (PD), Cardio Vascular Disease
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 A Kruse, PhD study director
JJCPPW
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2 mg nicotine gum and 4 mg nicotine gum in people with Dental Pellicle, run by McNeil AB.
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 5 inclusion and 2 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.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study was to assess, by using the MacPherson modification of the Lobene Stain Index, the amount of extrinsic tooth-stain reduction from Baseline while quitting smoking using Nicorette Freshmint gum (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.