Evidence map›Paper›PMID 39198824›Full record

ArticleBMC oral health2024

A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study.

Pearl Fang, Melissa Adkins-Hempel, Tamara Lischka, Sarah Basile, D Brad Rindal, Matthew J Carpenter, Dorota T Kopycka-Kedzierawski, Jennifer Dahne, Sarah A Helseth, Douglas E Levy and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC oral health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05627596 (Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05627596 phase2completednot on this map

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

TypeinterventionalSponsorSandra JapuntichRan2023 to 2025Enrolled1,239ConditionsCigarette SmokingArmsAsk-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release, Nicotine lozenge
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Pearl FangBehavioral Health Equity Research Group, Hennepin Healthcare Research Institute, 701 Park Ave. S9.104, Minneapolis, MN, 55415, USA.
Melissa Adkins-HempelBehavioral Health Equity Research Group, Hennepin Healthcare Research Institute, 701 Park Ave. S9.104, Minneapolis, MN, 55415, USA.
Tamara LischkaKaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.
Sarah BasileHealthPartners Institute, 8170 33rd , Ave. S MS 21112R, Minneapolis, MN, 55440, USA.
D Brad RindalHealthPartners Institute, 8170 33rd , Ave. S MS 21112R, Minneapolis, MN, 55440, USA.
Matthew J CarpenterDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Dorota T Kopycka-KedzierawskiDepartment of Dentistry, Eastman Institute for Oral Health, University of Rochester Medical Center, 625 Elmwood Ave., Box 683, Rochester, NY, 14620, USA.
Jennifer DahneDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Sarah A HelsethDepartment of Psychiatry and Behavioral Health, Center for Dissemination and Implementation Science, Northwestern University Feinberg School of Medicine, 633 N. St. Clair St., Suite 2000, Chicago, IL, 60611, USA.
Douglas E LevyMongan Institute Health Policy Research Center and Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St, Boston, MA, 02114, USA.
Arthur TruongKaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.
Michael C LeoKaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.
Kimberly FunkhouserKaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.
David R LouisHealth Partners Dental Group, 8455 Flying Cloud Dr., Eden Prairie, MN, 55344, USA.
Sandra J JapuntichBehavioral Health Equity Research Group, Hennepin Healthcare Research Institute, 701 Park Ave. S9.104, Minneapolis, MN, 55415, USA. Sandra.Japuntich@hcmed.org.
National Dental PBRN Collaborative group

Funding

The National Dental PBRN - Administrative CoreU19DE028717 · NIDCR · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILBERT, GREGG H · 2019 to 2025
$23.5M
NDPBRN Opioid SurveyU01DE028727 · NIDCR · KAISER FOUNDATION RESEARCH INSTITUTE · PI CARMIT Kurn MCMULLEN · 2019 to 2026
$16.0M
Effectiveness of Nicotine Replacement Therapy Sampling in Dental PracticesUH3DE029973 · NIDCR · HENNEPIN HEALTHCARE RESEARCH INSTITUTE · PI JAPUNTICH, SANDRA JANE · 2022 to 2024
$2.0M
NIDCR NIH HHS U01 DE028727NIDCR NIH HHS U19 DE028717NIDCR NIH HHS UH3 DE029973NIDCR NIH HHS UH3-DE-029973, U19-DE-028717 and U01-DE-028727
6 · The paper itself

Abstract

backgroundCigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings.

methodsThis manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke-regardless of interest in quitting- are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS. DISCUSSION: This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke.

trial registrationRegistered at ClincalTrials.gov (NCT05627596) on 11/25/2022.

Indexed as

Smoking CessationTobacco Use Cessation DevicesAdultClinical Trials, Phase II as TopicHumansNicotine Replacement TherapyRandomized Controlled Trials as TopicUnited StatesClinical trialNicotine replacement therapyNicotine replacement therapy samplingOral healthStudy protocolTobacco use

Identifiers

PMID39198824
PMCPMC11360338

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.