Oral DiseaseNCT02347124

Promoting Oral Health Among Smokers Randomized Trial

A study testing Enhanced Intervention in people with Oral Disease and Smoking, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oral Disease, Smoking
What is being tested?: Enhanced Intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 718 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged 18 or older
Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
Can read and speak in English
Current daily smoker and smokes at least 5 cigarettes a day
Interested in quitting smoking in next 30 days
Have some or all natural teeth

Show all 11Show fewer

Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
Has a cell phone capable of receiving text messages and provides cell phone number
Has internet access for personal use
Willing to talk about ways to improve their oral health
Provides verbal consent to participate

Who cannot join

Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
Have lived at the current address less than 6 months or plans to move in the next 6 months
Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
Has a household member already enrolled in the study, based on self-report and/or mailing address on file

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Promoting Oral Health Among Tobacco Quitline Callers

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].
Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome].
Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Read the detailed description

Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.

Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.

Conditions: Oral Disease, Smoking
Being tested: Usual Care Control, Enhanced Intervention
Keywords: smoking cessation, oral health care, tobacco quitlines
Medical subject headings: Mouth Diseases, Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual Care ControlBehavioural
Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
Enhanced InterventionBehavioural
Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)

Study groups in NCT02347124
Study group	Role	What they receive
Usual Care Control	Active comparator	Standard tobacco quitline counseling program and materials + attention-matched text messaging. Receives: Behavioral: Usual Care Control
Enhanced Intervention	Experimental	Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Receives: Behavioral: Enhanced Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

7 Day Point Prevalent Abstinence (PPA)
7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.
Measured: 6 month post-enrollment
Professional Dental Care Utilization in Past 6 Months
self-reported utilization of professional dental care during study observation period
Measured: 6 months post-enrollment

Secondary outcomes (3)

7 Day Point Prevalent Abstinence (PPA)
7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers
Measured: 2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.
Measured: 2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.
Measured: 6 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Mar 2017

First posted27 Jan 2015 (estimated)
Study startFeb 2015
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Oral DiseaseStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 718 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347124
Sponsor's protocol ID: 14-047-E
Other IDs: U01DE024462-01
Status last verified: Sep 2019
First submitted: 12 Jan 2015
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: We do not plan to share individual level data.

Publications

McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available.
PubMed 28750939
McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12.
PubMed 28412230
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
Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8.
PubMed 30382910

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Oral Health Among Tobacco Quitline Callers
ClinicalTrials.gov ID: NCT02347124
Acronym / sponsor ID: 14-047-E
Conditions: Oral Disease, Smoking
Keywords: smoking cessation, oral health care, tobacco quitlines
Study type: Interventional
Recruitment status: Completed
Enrolment: 718 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: Consumer Wellness Solutions, University of California, National Institute of Dental and Craniofacial Research (NIDCR)
Study start: Feb 2015 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 15 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].
Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome].
Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care Control	Active comparator	Behavioral: Usual Care ControlStandard tobacco quitline counseling program and materials + attention-matched text messaging.
Enhanced Intervention	Experimental	Behavioral: Enhanced InterventionStandard tobacco quitline counseling program and materials + multi-modal oral health promotion program .

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female, aged 18 or older
Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
Can read and speak in English
Current daily smoker and smokes at least 5 cigarettes a day
Interested in quitting smoking in next 30 days

Key exclusion criteria (4 listed)

Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
Have lived at the current address less than 6 months or plans to move in the next 6 months
Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
Has a household member already enrolled in the study, based on self-report and/or mailing address on file

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
Usual Care ControlStandard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Behavioural	Usual Care Control
Enhanced InterventionStandard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)	Behavioural	Enhanced Intervention

Primary outcome

7 Day Point Prevalent Abstinence (PPA)
Time frame: 6 month post-enrollment
7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.
Professional Dental Care Utilization in Past 6 Months
Time frame: 6 months post-enrollment
self-reported utilization of professional dental care during study observation period

3 secondary outcomes

7 Day Point Prevalent Abstinence (PPA)
Time frame: 2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)
Time frame: 2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)
Time frame: 6 months post-enrollment

Results and safety

Results posted to the registry on 15 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care Control	360	267
Enhanced Intervention	358	259

Primary outcome: 7 Day Point Prevalent Abstinence (PPA)

Time frame: 6 month post-enrollment. Count of participants. Unit: Participants

Measure	Usual Care Control n = 360	Enhanced Intervention n = 358
Value	109	121

Usual Care Control vs Enhanced Intervention: Odds Ratio (OR): 1.29 (95% CI 0.93 to 1.78), p = 0.13, Regression, Logistic

Population analysed: All participants with missing data imputed as smokers.

Primary outcome: Professional Dental Care Utilization in Past 6 Months

Time frame: 6 months post-enrollment. Count of participants. Unit: Participants

Measure	Usual Care Control n = 360	Enhanced Intervention n = 358
Value	67	65

Usual Care Control vs Enhanced Intervention: Odds Ratio (OR): 1.03 (95% CI 0.69 to 1.53), p = 0.90, Regression, Logistic

Population analysed: All participants with missing data imputed as not having seen a dentist.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care Control	0 of 360 (0%)	11 of 360 (3.1%)	2 of 360
Enhanced Intervention	3 of 358 (0.8%)	7 of 358 (2%)	0 of 358

Limitations and caveats (from the sponsor): The study relied on self-reported smoking and dental care. The focus on socio-economically disadvantaged smokers limits our ability to draw conclusions about the effectiveness of the intervention if offered to higher SES smokers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28750939McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available.
Background: PubMed 28412230McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12.
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.
Derived from this study: PubMed 30382910Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8.
Individual participant dataSharing planned: No. We do not plan to share individual level data.

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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.

Jennifer McClure, PhD principal investigator

Kaiser Permanente

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Intervention in people with Oral Disease and Smoking, run by Kaiser Permanente at 1 site in United States.

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 11 inclusion and 4 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 8 Oct 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

7 Day Point Prevalent Abstinence (PPA) (time frame: 6 month post-enrollment). The study lists 2 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 NCT02347124, which also lists 4 linked publications.

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 8 Oct 2019.