Changes in Oral Health and Dental Esthetic in Smokers Switching to Combustion-Free Nicotine Alternatives: Protocol for a Multicenter and Prospective Randomized Controlled Trial

被引：2

作者：

Conte, Gianluca ^{[1
]}

Pacino, Sebastiano Antonio ^{[1
,2
]}

Urso, Salvatore ^{[2
,3
]}

Greiling, Doris ^{[4
]}

Caponnetto, Pasquale ^{[5
,6
]}

Pedulla, Eugenio ^{[5
,7
]}

Generali, Luigi ^{[8
]}

Consolo, Ugo ^{[8
]}

Checchi, Vittorio ^{[8
]}

Gospodaru, Stefan ^{[9
]}

Bordeniuc, Gheorghe ^{[9
]}

Fala, Valeriu ^{[9
]}

Kowalski, Jan ^{[10
]}

Nowak, Maciej ^{[10
]}

Gorska, Renata ^{[10
]}

Amaliya, Amaliya ^{[11
]}

Chapple, Iain ^{[12
,13
]}

Milward, Michael ^{[12
,13
]}

Maclure, Robert ^{[14
]}

Nardi, Gianna Maria ^{[15
]}

Polosa, Riccardo ^{[16
]}

机构：

[1] Addendo Srl, Dent Clin, Catania, Italy

[2] Univ Catania, ECLAT Srl, Spin Off, Catania, Italy

[3] Univ Catania, Dept Biol Geol & Environm Sci, Catania, Italy

[4] Forsch Dock CRO GmbH, Schenefeld, Germany

[5] Univ Catania, Ctr Excellence Accelerat HArm Reduct, Catania, Italy

[6] Univ Catania, Dept Educ Sci, Sect Psychol, Catania, Italy

[7] Univ Catania, Dept Gen Surg & Med Surg Specialties, Catania, Italy

[8] Univ Modena & Reggio Emilia, Dept Surg Med Dent & Morphol Sci Transplant Surg, Oncol & Regenerat Med Relevance, Modena, Italy

[9] Faladental, Chiinau, Moldova

[10] Med Univ Warsaw, Dept Periodontol, Warsaw, Poland

[11] Univ Padjadjaran, Fac Dent, Dept Periodontol, Java, Indonesia

[12] Univ Birmingham, Periodontal Res Grp, Birmingham, England

[13] Birmingham Community Healthcare Trust, Birmingham, England

[14] R Maclure Clin Res Ltd, Irby, Wirral, England

[15] Sapienza Univ Rome, Dept Dent & Maxillofacial Sci, Pediat Dent Unit, Rome, Italy

[16] Univ Catania, Dept Clin & Expt Med, Via S Sofia 78,Ed 4,P 2, I-95123 Catania, Italy

来源：

JMIR RESEARCH PROTOCOLS | 2024年 / 13卷

关键词：

electronic cigarettes; heated tobacco products; tobacco harm reduction; smoking; oral health; gingivitis; periodontitis; Modified Gingival Index; MGI; dental plaque imaging; dental shade; smartphone; mobile phone; SMOKING-CESSATION; TOBACCO USE; GINGIVAL HEALTH; ESSENTIAL-OIL; PERIODONTITIS; CLASSIFICATION; DISCOLORATION; CIGARETTES; EXPOSURE; DISEASES;

D O I：

10.2196/53222

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Background: Although the detrimental effects of conventional combustible cigarettes on oral health and dental esthetics are well known, there is limited information about the long-term impact of combustion -free nicotine alternatives (C -F NA) such as e -cigarettes or heated tobacco products. Objective: This multicenter, prospective, 3 -parallel -arm randomized controlled trial will investigate whether switching from combustible cigarettes to C -F NA will lead to measurable improvements in oral health parameters and dental esthetics over 18 months in adult smokers with limited gum disease. Methods: Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (control group; arm A) or C -F NA use (intervention group; arm B). The study will also include a reference group of never smokers (reference group; arm C). The primary end point is the change in the Modified Gingival Index (MGI) score from baseline between the control arm (arm A) and the intervention arm (arm B) at the 18 -month follow-up. In addition, the study will analyze the within- and between -group (arms A, B, and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stain scores, and oral health-related quality of life questionnaires measured at each study time point. All participants will attend a total of 7 clinic visits: screening, enrollment, and randomization (visit 0); baseline visit-day 14 (visit 1); day 90 (visit 2); day 180 (visit 3); day 360 (visit 4); and day 540 (visit 5). This multicenter study will be conducted in 4 dental clinics in 4 countries. The statistical analysis will involve descriptive statistics for continuous and categorical data. Primary end points will undergo tests for normality and, based on distribution, either a 2 -sided t test or Mann -Whitney U test. Linear mixed model with random factors center and study arms by center will also be applied. Secondary end points, including MGI assessment and quality of life, will be subjected to similar tests and comparisons. Only if one value of the parameter MGI is missing after day 1, the last available observation will be carried forward. The analysis will be performed on the substituted data. Secondary parameters will not have missing value replacement. Results: Participant recruitment began in October 2021, and enrollment was completed in June 2023. Results will be reported in 2025. Conclusions: This will be the first study to provide key insights into oral health benefits or risks associated with using C -F NA in smokers who are seeking alternatives to cigarette smoking. Trial Registration: ClinicalTrials.gov NCT04649645; https://clinicaltrials.gov/ct2/show/NCT04649645 International Registered Report Identifier (IRRID): DERR1-10.2196/53222

引用

页数：18

共 52 条

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