Smoking CessationTISODNCT02737176
Tobacco Cessation Intervention Study for Oral Diseases
A study testing Tobacco cessation intervention in people with Smoking Cessation and Mouth Diseases, run by Association for the Japanese Academy of Maxillofacial Implants at 2 sites in Japan.
Trial summary
This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Smoking Cessation, Mouth Diseases, Periodontal Diseases
- What is being tested?
- Tobacco cessation intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 2 sitesJapan
- Study dates
- Apr 2016to Dec 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smokers with periodontitis; 30% or more of the teeth where periodontal pocket depth (PPD) is 4mm or more and 3 or more sites in 6mm or more of the PPD
- Current smokers in patients about to receive implant placement
- Current smokers with oral mucosal diseases clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythroplakia and oral lichen planus
Who cannot join
- Already having any cessation intervention
- Periodontitis with having anti-inflammatory drug or steroid use and have had periodontal treatment within 6 months
- Oral mucosal diseases having had surgical resections or other interventional treatments
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Shin Yurigaoka General Hospital
Kawasaki, Kanagawa, 215-0026
Jinichi Fukuda, DDS, PhD, +81-44-322-9991, jinichi.fukuda@gmail.com
- Recruiting
Okazaki City Hospital
Okazaki, Aichi-ken, 444-8553
Toru Nagao, PhD, DDS, +81-564-21-8111, tnagao@dpc.agu.ac.jp
About this study
Official title: Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.
Read the detailed description
It has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (Cochrane Database Syst Rev.6:CD005084.) However, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. There are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. Association for the Japanese Academy of Maxillofacial Implants, Association for the Japanese Society of Oral and Maxillofacial Surgeons, Association for the Japanese Society of Oral Implantology, Japanese Society of Oral Medicine, Japanese Society of Periodontology, Japanese Academy of Clinical Periodontology, Japanese Society for Oral Health, Japanese Society of Dentistry for Medically Compromised Patient and Japanese Society of Oral Oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.
- Conditions
- Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Lichen Planus, Keratosis
- Being tested
- Tobacco cessation intervention
- Keywords
- Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Keratosis, Implant, Lichen Planus
- Medical subject headings
- Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Lichen Planus, Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco cessation interventionOther
The nicotine dependence status is evaluated by the Fagerstrom Test for Nicotine Dependence test; those who 3 or more score are eligible for the intervention.
During the study, attending doctors implement a tobacco cessation intervention with standard treatments for above oral diseases.
Even if the subjects failed to abstain from smoking, the treatment is continued.
In case of the use of the nicotine replacement therapy, The investigators supply NRTs (nicotine patch or gum) for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco cessation intervention | Experimental | Tobacco cessation intervention is implemented for 12 weeks. The nicotine dependence status is evaluated by the FTND (Fagerstrom Test for Nicotine Dependence) test. The point 3 or more is regarded as a moderate or high tobacco dependence and determining a cessation intervention. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Even if participants fail to abstain from smoking, the oral treatment is continued. In case of the use of the NRTs (nicotine patch and/or gum), the investigators supply it for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy. Receives: Other: Tobacco cessation intervention |
| Non-tobacco cessation intervention | No intervention | Those who do not intention to abstinence from smoking strongly and/or having less than 3 points in FTND test are allocated to non-tobacco cessation intervention group. The same treatment as the tobacco cessation intervention group is carried out for their oral diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth in peridontitis
Pocket depth and attachment loss with or without surgical treatment
Measured: Change from baseline at 12 months
Per-implant marginal bone loss
Per-implant marginal bone loss by a standardized X-ray photo
Measured: Change from baseline at 12 months
Size reduction of oral mucosal diseases
Size reduction (major x minor axis /mm) at a predominant site for non-surgical group
Measured: Change from baseline at 12 months
Secondary outcomes (2)
Tobacco abstinence rate
Biochemical validation tests confirming for quit smoking is applied for all subjects. Measurements of expired carbon monoxide (CO) where the test is available are analyzed at each period. Otherwise cotinine levels of the saliva samples are analyzed by a semi-quantitative analysis by NicAlert™.
Measured: 3,6,12 and 24 months
HPV-DNA detection (p16 & 18)
The oral mucosa tissues are collected by buccal swab.
Measured: pre- and post-treatment (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
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 Smoking CessationStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association for the Japanese Academy of Maxillofacial Implants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants
- Investigators
- Jinichi Fukuda, PhD, DDS, Study chair, Shin-Yurigaoka General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737176
- Sponsor's protocol ID
- AssociationJAMI
- Acronym
- TISOD
- Status last verified
- Jul 2016
- First submitted
- 31 Mar 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
- ClinicalTrials.gov ID
- NCT02737176
- Acronym / sponsor ID
- TISOD / AssociationJAMI
- Conditions
- Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Lichen Planus, Keratosis
- Keywords
- Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Keratosis, Implant, Lichen Planus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 812 participants (estimated)
- Lead sponsor
- Association for the Japanese Academy of Maxillofacial ImplantsUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Apr 2016 (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.
This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.
Detailed description
It has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (Cochrane Database Syst Rev.6:CD005084.) However, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. There are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. Association for the Japanese Academy of Maxillofacial Implants, Association for the Japanese Society of Oral and Maxillofacial Surgeons, Association for the Japanese Society of Oral Implantology, Japanese Society of Oral Medicine, Japanese Society of Periodontology, Japanese Academy of Clinical Periodontology, Japanese Society for Oral Health, Japanese Society of Dentistry for Medically Compromised Patient and Japanese Society of Oral Oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco cessation intervention | Experimental | Other: Tobacco cessation interventionTobacco cessation intervention is implemented for 12 weeks. The nicotine dependence status is evaluated by the FTND (Fagerstrom Test for Nicotine Dependence) test. The point 3 or more is regarded as a moderate or high tobacco dependence and determining a cessation intervention. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Even if participants fail to abstain from smoking, the oral treatment is continued. In case of the use of the NRTs (nicotine patch and/or gum), the investigators supply it for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy. |
| Non-tobacco cessation intervention | No intervention | –Those who do not intention to abstinence from smoking strongly and/or having less than 3 points in FTND test are allocated to non-tobacco cessation intervention group. The same treatment as the tobacco cessation intervention group is carried out for their oral diseases. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current smokers with periodontitis; 30% or more of the teeth where periodontal pocket depth (PPD) is 4mm or more and 3 or more sites in 6mm or more of the PPD
- Current smokers in patients about to receive implant placement
- Current smokers with oral mucosal diseases clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythroplakia and oral lichen planus
Key exclusion criteria (3 listed)
- Already having any cessation intervention
- Periodontitis with having anti-inflammatory drug or steroid use and have had periodontal treatment within 6 months
- Oral mucosal diseases having had surgical resections or other interventional treatments
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 |
|---|---|---|
| Tobacco cessation interventionThe nicotine dependence status is evaluated by the Fagerstrom Test for Nicotine Dependence test; those who 3 or more score are eligible for the intervention. During the study, attending doctors implement a tobacco cessation intervention with standard treatments for above oral diseases. Even if the subjects failed to abstain from smoking, the treatment is continued. In case of the use of the nicotine replacement therapy, The investigators supply NRTs (nicotine patch or gum) for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy. | Other | Tobacco cessation intervention |
Primary outcome
Pocket depth in peridontitis
Time frame: Change from baseline at 12 months
Pocket depth and attachment loss with or without surgical treatment
Per-implant marginal bone loss
Time frame: Change from baseline at 12 months
Per-implant marginal bone loss by a standardized X-ray photo
Size reduction of oral mucosal diseases
Time frame: Change from baseline at 12 months
Size reduction (major x minor axis /mm) at a predominant site for non-surgical group
2 secondary outcomes
Tobacco abstinence rate
Time frame: 3,6,12 and 24 months
HPV-DNA detection (p16 & 18)
Time frame: pre- and post-treatment (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Derived from this study: PubMed 33605440Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
- Individual participant dataSharing planned: No
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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.
Jinichi Fukuda, PhD, DDS study chair
Shin-Yurigaoka General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco cessation intervention in people with Smoking Cessation and Mouth Diseases, run by Association for the Japanese Academy of Maxillofacial Implants at 2 sites in Japan.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toru Nagao, PhD, DDS (+81-564-21-8111 ext. 7817, tnagao@dpc.agu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth in peridontitis (time frame: Change from baseline at 12 months). The study lists 3 primary outcomes in all. 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 NCT02737176, 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 1 Aug 2016.