OBJECTIVES:Inflammatory bowel disease (IBD) encompasses a spectrum of chronic disorders of the gastrointestinal tract, with a potential bidirectional relationship with periodontitis. Neutrophils are key regulators of immune-inflammatory responses and play a major role in both diseases. Isolating and characterizing gut lumen neutrophils may help to map the evolution of cell phenotypes from peripheral blood to saliva and help explain certain mechanistic relationships within the oral-gut axis. This review aims to critically evaluate the biological sources of human neutrophils and the emerging analytical approaches to their study in IBD. MATERIALS AND METHODS:Studies employing various methodological strategies to isolate and analyze neutrophils derived from both systemic (peripheral blood) and mucosal compartments in IBD are synthesized. Data obtained through different analytical modalities are discussed. RESULTS:Neutrophils play multifaceted roles in IBD beyond their traditional function in pathogen clearance and acute inflammation. They contribute to both tissue injury and repair through the release of proteolytic enzymes, reactive oxygen species, cytokines, and neutrophil extracellular traps. Recent advances in analytical technologies have uncovered remarkable phenotypic and functional diversity, shaped by the local microenvironment within the intestinal mucosa. CONCLUSIONS:Neutrophils' ability to both exacerbate mucosal damage and facilitate resolution of inflammation underscores the need for improved methodological approaches that enable precise characterization of their functional states in both systemic and tissue contexts. CLINICAL RELEVANCE:Improved phenotypic and functional profiling of neutrophils may facilitate the identification of biomarkers predictive of disease activity, treatment response, and relapse risk, and contribute to the understanding of the role of neutrophils in the interplay between IBD and periodontitis.
AIM:To examine whether the oral microbiota of e-cigarette users differs from that of never smokers and current smokers. MATERIALS AND METHODS:PubMed, Scopus and Web of Science were searched on 27 August 2025. Human studies using molecular methods to compare oral microbiota in saliva, subgingival plaque and oral mucosal swabs among e-cigarette users, never smokers and current smokers were included. Primary outcomes were alpha diversity, beta diversity and differential taxonomic abundance. Risk of bias was assessed using JBI tools and certainty of evidence using GRADE. RESULTS:Twelve studies were included; most were cross-sectional and heterogeneous in design, exposure and samples. Alpha diversity findings were inconsistent across samples, whereas beta diversity more consistently indicated distinct microbial communities in e-cigarette users compared with never smokers and current smokers. Taxonomic differences were heterogeneous and sample-dependent, with some enrichment of genera such as Veillonella, Leptotrichia, and Fusobacterium compared with never smokers. CONCLUSIONS:Electronic cigarette use is associated with sample-specific oral microbiota differences that partly overlap with, but differ from, those observed in never smokers and current smokers. However, the certainty of evidence is very low due to predominantly cross-sectional designs and methodological limitations, underscoring the need for longitudinal studies with standardised exposure and protocols.
The effects and treatment of periodontitis go beyond the inflammatory lesion of the periodontium, with sequelae of Stage IV and sometimes Stage III disease requiring rehabilitation of the dentition. In October 2022, the British Society of Periodontology carried out an adolopment process (in a similar fashion to the Stage I–III guideline) for the European Federation of Periodontology's S3 Clinical Guideline for the Treatment of Stage IV Periodontitis. This article covers the structure of an S3-level guideline in general and the adoloped recommendations across all case types for this specific guideline document.
BACKGROUND:The European Federation of Periodontology (EFP) has developed Clinical Practice Guidelines (CPGs) for the treatment of periodontitis and for the management of peri-implant diseases. In accordance with the 2018 Classification, acute periodontal conditions are characterised by rapid-onset pain or discomfort, tissue destruction and infection. Therefore, the development of a CPG to guide patients and clinicians in their management is justified. AIM:To develop an S2k-level CPG for the management of acute periodontal conditions, necrotising periodontal diseases, periodontal abscesses and acute manifestations of endodontic-periodontal lesions. METHODS:This S2k-level CPG was developed by the EFP, following methodological guidance from the Association of Scientific Medical Societies in Germany and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process. A rigorous and transparent process included synthesis of relevant research in two commissioned systematic reviews, evaluation of the quality and strength of evidence, formulation of specific recommendations and a structured consensus process involving leading experts and a broad base of stakeholders. Recommendations were based on the best available evidence, combined with structured expert consensus, particularly in areas where direct evidence remains scarce. RESULTS:The S2k-level CPG for the management of acute periodontal conditions presents a structured approach, grouping the recommendations in three successive steps: (1) confirming diagnosis, following the case definitions of the 2018 classification; (2) initial treatment, to control the acute condition including pain and active tissue destruction; and (3) subsequent treatments, to manage the pre-existing conditions and prevent the risk of disease recurrence and/or control the potential sequelae. CONCLUSION:The present S2k-level CPG informs clinical practice, health systems, policymakers and, indirectly, the public on the available and most effective interventions in the management of acute periodontal conditions.
ABSTRACT Objective: To compare two protocols for adjunctive exercise prescription – before or after subgingival instrumentation (SI) – during periodontal therapy. Material and Methods: Twenty-four patients were randomly allocated into two groups and evaluated at 3-time points (T0 – Baseline, T1 – 45 days, T2 – 90 days). Group 1 (n=10) received SI at T0, re-evaluation and exercise at T1, and final re-evaluation at T2. Group 2 (n=14) started exercising at T0, received re-evaluation and SI at T1, and final re-evaluation at T2. Clinical parameters included probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BoP), and plaque index. Crevicular fluid was analyzed by multiplex immunoassay. The exercise lasted 7 minutes and was performed 3 times/week using an app. Results: Twenty-four patients completed the study. All clinical parameters improved at T2. Group 2, but not Group 1, significantly improved BoP and CAL at T1. There was no significant interaction or intergroup differences for any clinical parameter. For initial PD≥4mm sites, both groups showed significant reductions in PD and CAL at both time points. Only IL-1β and IFN-γ were significantly reduced for both groups at T2. Conclusion: Both exercise/SI protocols improved periodontal parameters after 90 days.
In 2024, World Health Organization (WHO) member states endorsed the Bangkok declaration, prioritising oral diseases within universal health coverage and non-communicable disease agendas, and calling for prevention-oriented, primary care-led systems. This study aimed to: (1) explore the healthcare costs of managing dental caries between the ages of 12 and 65 years across income quintiles in 40 countries, and (2) estimate the potential reduction in direct costs from non-targeted and targeted oral health-promoting interventions. A cohort simulation model was developed to estimate the direct costs of dental caries over time for different income quintiles across 40 countries. National-level DMFT (dentine threshold) data, the relative likelihood of receiving an intervention (such as a restorative procedure, tooth extraction and replacement), and clinically guided assumptions were used to populate the model. Private treatment costs in each country were used as a proxy to estimate the direct costs of dental caries. A hypothetical group of upstream and downstream preventive interventions were applied either uniformly across all income groups to reduce caries progression rates by 30
Tobacco smoking remains the most consistent and preventable risk factor for oral cancer, driven by exposure to combustion-derived toxins that promote DNA damage, inflammation and microbiota dysregulation. Global data show substantial geographic variability in disease burden, with particularly high incidence and mortality especially in South and Southeast Asia, where culturally reinforced and deeply embedded forms of high-nitrosamine smokeless tobacco and areca nut continue to drive risk. In this evolving landscape, nicotine pouches have rapidly expanded as tobacco-free oral products manufactured to deliver nicotine without combustion. Toxicological analyses reveal significantly lower levels of harmful constituents relative to cigarettes and traditional smokeless tobacco, and short-term clinical studies report reductions in oral mucosal irritation and gingival inflammation among exclusive users. However, no long-term epidemiological evidence is currently available to assess their potential impact upon oral carcinogenesis, and existing human studies remain few, small and heterogeneous. This mini review highlights critical priorities for research, including the need for long-term prospective studies, standardized product testing, independent toxicological assessments and surveillance of patterns of use, dual use and youth uptake. The integration of harm reduction approaches with established prevention strategies may offer opportunities to mitigate oral cancer risk in adults who smoke and/or consume unregulated smokeless tobacco products with high risk profiles that are very common in Asia, the Middle East and Africa. However, this approach requires cautious interpretation of the current evidence and ongoing monitoring of emerging products.
Irisin is an extracellular peptide stimulated by exercise and could act as both a biomarker and mediate the positive impact of exercise. This scoping review synthesizes human evidence on irisin variations in non-communicable diseases, showing an increase of irisin in saliva and gingival tissues in periodontitis, potentially reflecting reparative or immunomodulatory activity.
Background: Electric toothbrushes are known to outperform manual devices in plaque removal, yet most comparative trials rely on conventional examiner-based indices and none have evaluated efficacy across smoking profiles using objective fluorescence-based measurement. Methods: This 24-week, 2-arm, parallel-group randomized controlled trial compared an oscillating-rotating electric toothbrush (Oral-B iO 6) with a manual toothbrush in 126 adults aged 18 to 50 years attending a dental clinic for routine scaling and polishing. Current smokers and never-smokers were enrolled to allow prespecified subgroup analysis by smoking status. Dental plaque accumulation was quantified using quantitative light-induced fluorescence (QLF) technology. The primary endpoint was ΔR30 (percentage of tooth surface with fluorescence increase ≥30%, reflecting total mature plaque); ΔR120 (fluorescence increase ≥120%, reflecting thick plaque and calculus-like deposits) was the secondary endpoint. The primary analysis used analysis of covariance adjusting for baseline plaque levels, treatment arm, smoking status, and their interaction. Results: Use of the electric toothbrush was associated with significantly lower ΔR30 at 24 weeks compared with manual brushing (β = −1.84, 95% CI [−3.27, −0.41], p = .012), an effect that remained robust after adjustment for age, sex, and habitual oral hygiene behaviours. Baseline plaque level was the strongest predictor of follow-up values in both outcome models. No significant treatment effect was observed for ΔR120 (β = −0.77, 95% CI [−1.71, 0.18], p = .112). Subgroup analyses showed significant between-arm differences on both outcomes among never-smokers; among smokers, differences were directionally consistent but did not reach statistical significance, and the treatment-by-smoking interaction was not statistically significant. Conclusions: Oscillating-rotating electric toothbrushing produced significantly lower plaque accumulation than manual brushing over 24 weeks, as indexed by QLF-derived ΔR30. These findings support the potential advantage of oscillating-rotating powered toothbrushes for reducing plaque accumulation in adult patients and further support the utility of QLF as a precise and reproducible outcome measure for toothbrush efficacy trials. Clinical trial registration: ClinicalTrials.gov, NCT06358482.
OBJECTIVE:Periodontitis, a highly prevalent chronic inflammatory disease, is characterized by the progressive destruction of the tooth-supporting tissues, ultimately causing tooth loss. In recent years, the emerging field of immunometabolism has revealed that immune cell function is tightly regulated by intracellular metabolic pathways that govern cellular activation, differentiation, and effector responses. Therefore, the aim of this review was to synthesize current evidence on the role of immunometabolism in the pathogenesis of periodontitis, with a particular focus on how metabolic reprogramming regulates innate and adaptive immune responses, contributes to inflammatory bone loss, and represents a potential target for host-modulatory therapies. MATERIALS AND METHODS:A comprehensive narrative review of the contemporary literature was conducted to integrate experimental, translational, and clinical evidence on immunometabolic mechanisms involved in periodontitis. The review examines metabolic regulation of innate and adaptive immune cells, the influence of microbial and systemic metabolic signals on periodontal inflammation, and emerging therapeutic strategies targeting immunometabolic pathways. RESULTS:Current evidence demonstrates that persistent microbial challenge and inflammatory signaling induce profound metabolic reprogramming of immune cells within the periodontal microenvironment. Activated neutrophils, macrophages, dendritic cells, and lymphocytes undergo coordinated shifts in glycolysis, mitochondrial oxidative phosphorylation, fatty acid oxidation, and amino acid metabolism, which regulate immune cell activation, differentiation, and effector functions. These metabolic adaptations promote the production of reactive oxygen species, pro-inflammatory cytokines, and osteoclastogenic mediators, thereby amplifying inflammation and disrupting osteoimmune mechanisms that maintain bone homeostasis. In addition, microbial-derived metabolites further influence host immune metabolism, reinforcing chronic inflammation and periodontal tissue destruction. Emerging preclinical evidence suggests that pharmacological modulation of key immunometabolic pathways may attenuate inflammation and preserve periodontal tissues. CONCLUSION:Immunometabolic reprogramming is a fundamental mechanism linking microbial dysbiosis to dysregulated host immunity and inflammatory bone loss in periodontitis. A better understanding of the metabolic pathways governing immune cell function may provide important mechanistic insights into disease pathogenesis. By integrating insights from (osteo-)immunology and metabolism, this review proposes immunometabolism as a critical determinant of inflammatory bone loss and a fruitful avenue for the development of novel host-modulatory periodontal therapies aimed at restoring immune homeostasis and preventing periodontal tissue destruction.
BACKGROUND:The objectives of this Focused Workshop were to update the epidemiology, aetiology, risk factors, diagnosis and management of gingival and periodontal diseases and conditions in children and adolescents, and to explore the applicability of the 2018 Classification in children and adolescents. METHODS:The Workshop discussions were informed by three specifically commissioned systematic reviews covering gingival and periodontal diseases and conditions, in systemically healthy children and adolescents, or in children and adolescents with systemic conditions. RESULTS:Over 70 genetic, congenital and acquired systemic conditions that impact the periodontal tissues were identified, with levels of evidence graded as very low, low or moderate. Gingival diseases and conditions in systemically healthy children and adolescents were identified, alongside local predisposing and systemic modifying factors. Periodontitis and other periodontal conditions in the 2018 Classification System also apply to children and adolescents; however, there are challenges with periodontal probing in the primary and mixed dentition. CONCLUSIONS:Periodontal tissues in children and adolescents differ from those in adults and require special consideration, accounting for their stage of development and predisposing and modifying factors unique to younger patients, which may confound accurate diagnosis, prognostication and management. Specific approaches to screening, examination and treatment are necessary for safe and effective management in this patient group.
Imbalances within the oral microbiome, composed of over 700 phylotypes, drive both local diseases, including periodontitis, and systemic conditions, such as rheumatoid arthritis and cardiovascular disease. Given the overuse of conventional antimicrobial agents to manage oral diseases and the relapsing nature associated with current intervention strategies, innovative promicrobial approaches to oral biofilm community restoration are needed. Importantly, there is a critical unmet clinical need for active restoration and sustained delivery of beneficial oral commensals rather than continued disruption of already-imbalanced communities. We have developed a promicrobial formulation encapsulating live, health-associated, oral bacteria within mucoadhesive micro-composites to promote the establishment of beneficial biofilms under simulated oral flow conditions. We encapsulated and characterised a five-species bioactive consortia of oral bacteria in alginate micro-composites, surface modified with poly-L-lysine to enhance their adhesion to artificial saliva-coated surfaces in vitro. Dissemination of the encapsulated bacteria from the micro-composites led to the formation of stable oral biofilms. Notably, biofilm composition could be modulated by altering the encapsulated bioactive composition, enabling a tailored and targeted pathway to biofilm restoration. Under representative saliva flow, delivery of bioactives following their bioencapsulation resulted in strong biofilm-forming capacity, even in the presence of pre-existing oral bacterial communities containing pathobionts, highlighting their potential clinical applications in dental biofilm bioengineering. In experiments designed to simulate periodontal pocket debridement, we observed immunomodulation following treatment with bioactive formulations and pathobiont reduction when Limosilactobacillus reuteri was also incorporated into the consortia. These findings establish a framework for using sustained-release encapsulated probiotics to modulate the oral microbiome, offering a paradigm shift towards biofilm-promoting therapies for oral healthcare and paving the way for oral microbiome transplantation.
OBJECTIVES:Smoking poses a significant challenge to oral health, particularly in individuals with dental and periodontal disease. This expert review explores the dual burden of managing periodontal and dental care in smokers, emphasizing the impact of chronic tobacco exposure on disease progression and treatment outcomes. STUDY SELECTION, DATA, AND SOURCES:Clinical trials, systematic reviews, and international guidelines were consulted where available. Search terms specific to the topic were entered into PubMed, Scopus, and Google Scholar to identify the most relevant literature. RESULTS:Chronic smoking accelerates biofilm re-accumulation and periodontal tissue destruction, complicating treatment outcomes. Smoking cessation remains the most effective strategy for mitigating these risks, improving healing, reducing inflammation, and restoring microbiota balance. Dental professionals play a crucial role in integrating smoking cessation support into periodontal care through evidence-based interventions such as behavioral counseling, pharmacotherapy, and harm reduction strategies. Emerging technologies, including mobile health applications and remote monitoring, enhance patient engagement in smoking cessation efforts. Alternative nicotine products, such as e-cigarettes and heated tobacco products, may serve as harm reduction tools for smokers unwilling to quit, though their long-term effects on oral health remain unclear. CONCLUSIONS:A multidisciplinary approach that combines periodontal therapy with tailored smoking cessation interventions is essential for improving oral health outcomes in smokers. Future research should prioritize longitudinal studies to assess the effectiveness of integrated smoking cessation and periodontal treatment strategies. CLINICAL RELEVANCE:The integration of smoking cessation into routine dental care is essential to improve treatment outcomes and long-term oral health. This review emphasizes the need for evidence-based strategies to manage smokers in dental settings and highlights the importance of further research to refine clinical guidelines.
This review aims to summarise the current epidemiological evidence for associations between periodontitis and chronic kidney disease (CKD), and to explore the underlying biological mechanisms. CKD is strongly associated with periodontitis in both cross-sectional and longitudinal studies, with 2.5 higher odds of having periodontitis in the presence of CKD and 2-times higher likelihood of developing CKD in the presence of periodontitis. Patients with CKD and periodontitis have a hazard ratio of 3.1 for progression of CKD when pockets are greater than 4.5mm compared to without. The biological mechanisms underlying this relationship include common risk factors of smoking and diabetes, the systemic inflammatory burden posed by periodontitis, and the detrimental effect of periodontal pathogens on renal tissues. Evidence supports a bidirectional relationship between periodontitis and CKD whereby periodontal care may represent an important and novel management strategy for individuals with CKD.
BACKGROUND:This Consensus Workshop dealt with diagnostic methodologies in the context of surveillance, screening, assessment of stage and grade, prognosis, monitoring and prediction of periodontal status. Several elements provided the impetus for the workshop, including the limited quality of available research on diagnostic tests, the rapid development of new technologies, the implementation of the 2018 classification and the declarations of the World Health Organisation on diagnosis and oral health. AIM:To update and evaluate the evidence on diagnostic methods, considering recent advances in knowledge and the implementation of the 2018 classification. METHODS:The European Workshop Committee of the European Federation of Periodontology guided the development of a consensus report after commissioning eight systematic reviews within three working groups. The reviews were discussed during the in-person consensus meeting involving 70 participants from 21 different countries. RESULTS:Working Group 1 discussed innovations in traditional diagnostic approaches, justified manual probing as the reference standard and assessed the value of image-based methods. Working Group 2 analysed diagnostic tests based on microbial and host biomarkers and genetic diagnostic tests. Working Group 3 covered emerging technologies to be used within dental and non-dental clinical settings, focusing principally on the impact of questionnaire-based assessments and artificial intelligence systems (AIS) in interpreting different data modalities. CONCLUSION:Although manual periodontal probing is firmly established as the reference standard, additional approaches based on imaging, biomarkers, host genetics, questionnaires and the development of emerging applied data science methods (e.g., AIS) are increasingly integrated in periodontal diagnostics.
Tobacco use is a global issue, and non-combustible nicotine products (NCNPs) like electronic nicotine delivery systems, nicotine pouches, snus, and nicotine replacement therapies offer potential risk/harm reduction for smokers unable or unwilling to quit. Although NCNPs are less harmful than tobacco smoking, their impact on oral health remains unclear. A systematic review and network meta-analysis will be conducted to answer the research question: What are the oral signs and symptoms associated with NCNPs as both monotherapies and combination therapies compared to each other, placebo, standard care, no drug treatment, and combustible cigarette smoking? We will search PubMed and Scopus databases, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to August 2024. This review will focus on randomized controlled trials (RCTs) with a minimum follow-up period of 1 month, comparing any NCNPs versus placebo, standard care, no drug treatment, combustible cigarette smoking or to each other in adult smokers. Our primary outcomes will be the number of participants reporting any oral side effect, aphthous ulcers, dry mouth and mouth irritation. Studies will be excluded if they involve: non-smokers, pregnant women, individuals with mental health or neurological disorders, participants consuming alcohol or other substances. Data will be analyzed using a network meta-analysis framework, estimating odds ratios with 95
OBJECTIVES:To evaluate the oral adverse effects of non-combustible nicotine products (NCNPs) compared with each other, placebo, standard of care, no treatment and combustible cigarettes through a systematic review and network meta-analysis. DATA SOURCES AND STUDY SELECTION:Randomized controlled trials involving adult smokers and reporting oral adverse events (e.g., mouth irritation, dry mouth, aphthous ulcers) were included. PubMed, Scopus, and Cochrane CENTRAL were searched up to August 2024. Risk of bias was assessed using RoB 2, and evidence certainty with CINeMA. RESULTS:Thirty-six trials were included, with 21 contributing to the network meta-analysis. Most comparisons with placebo showed no significant differences across four primary outcomes. The odds of developing aphthous ulcers were significantly higher in the nicotine replacement therapy (NRT) gum group compared with standard of care (OR = 2.36; 95 % CI: 1.05-5.30). Higher odds of mouth irritation were also observed for e-cig (OR = 4.06; 95 % CI: 1.67-9.85), NRT mouth spray (OR = 4.36; 95 % CI: 1.14-16.63), NRT gum (OR = 4.25; 95 % CI: 1.51-11.94) and snus (OR = 13.56; 95 % CI: 1.07-171.52) when compared with standard of care. Sensitivity analyses confirmed the main findings. Secondary outcomes revealed isolated associations but were based on limited data. Evidence certainty was low to very low due mainly to imprecision and risk of bias. CONCLUSIONS:NCNPs appear to be generally well tolerated. Most placebo comparisons showed no increased risk, although some products exhibited higher odds of aphthous ulcers and mouth irritation compared with standard of care. Better reporting of oral adverse events in RCTs is needed. CLINICAL SIGNIFICANCE:Given the current limitations of the evidence base, dental professionals should play an active role in tobacco harm reduction strategies by monitoring oral health during NCNP use and supporting product choice based on safety, tolerability, and individual patient needs.
BACKGROUND:The oral microbiome plays a pivotal role in maintaining both oral and systemic health, yet it can be disrupted by lifestyle factors such as tobacco use. Electronic cigarette (e-cig) has emerged as a popular alternative to conventional smoking, often perceived as a harm reduction tool. While combustible tobacco smoking is known to promote pathogenic shifts in the oral microbiota, evidence on the impact of e-cig use remains limited and inconsistent. A systematic synthesis of current evidence is therefore warranted to assess the potential microbiological and clinical implications of e-cig use. This systematic review aims to critically evaluate clinical studies assessing the effects of e-cig use on the oral microbiome, with specific comparisons to current smokers and never smokers. METHODS:PubMed, Scopus, and Web of Science have been searched from 2010 up to August 27, 2025, using MeSH terms and free-text keywords related to e-cigs, vaping, oral microbiome, and microbial diversity. Eligible studies will include randomized controlled trials, cross-sectional, and longitudinal observational designs comparing e-cig users with current smokers and/or never smokers, and using culture-independent, next-generation sequencing techniques for microbiome profiling. Two reviewers will independently perform study selection, data extraction, and quality assessment using the Joanna Briggs Institute critical appraisal tools. Given expected heterogeneity, findings will be synthesized narratively and tabulated; subgroup analyses will examine differences according to oral health status, e-cig use patterns, and sampling site. RESULTS:Database searching was completed on Aug 27, 2025, and identified 39 records in PubMed, 46 in Scopus, and 83 in Web of Science. Secondary searches, including gray literature screening and snowballing, have not yet been conducted. Screening and selection of retrieved articles are in progress, with review completion expected by November 2025. DISCUSSION:This review is expected to provide a comprehensive and critical appraisal of the current evidence on the relationship between e-cig use and oral microbiome composition. By summarizing key microbial diversity patterns, identifying taxa-level differences, and highlighting methodological strengths and limitations, it will clarify the extent to which e-cig use may influence oral microbial communities. The anticipated heterogeneity in study designs, outcome measures, and sampling methods underscores the need for cautious interpretation and for standardization in future research. The findings aim to inform clinical understanding of potential local and systemic implications of e-cig use and to guide the design of robust, longitudinal studies with careful control of residual confounding. SYSTEMATIC REVIEW REGISTRATION:PROSPERO registration: CRD420251120281.
OBJECTIVES:To assess the completeness and quality of reporting of oral adverse events (OAEs) in randomized controlled trials (RCTs) that evaluated non-combustible nicotine products (NCNPs) and whether reporting practices have improved over time. DATA SOURCES AND STUDY SELECTION:This secondary data analysis was based on 36 RCTs included in a previous systematic review. Trials involved adult smokers and included nicotine replacement therapy, electronic cigarettes, heated tobacco, and smokeless tobacco. The OAE reporting was evaluated using an adapted CONSORT Harms checklist. An Adjusted Checklist Score (ACS), representing the proportion of criteria met, was calculated. Univariate linear regressions explored the association between ACS and study-level variables (publication year, country, funding, blinding and product type). RESULTS:OAE reporting was fragmented, with a mean ACS of 0.52 (0.11-0.74). Over 80 % of studies (n=30) provided some quantitative data, but only 53 % (n=19) presented results in a tabulated, arm-specific format. Definitions of OAEs and severity measurement were rarely reported (n=5, 14 % and n=6, 17 % respectively). The method of OAEs collection was described in 50 % of the studies (n=18). OAEs were rarely mentioned in titles (n=4, 11 %) and conclusions (n=13, 36 %). Less than half of the studies reported the reasons for participant withdrawal due to AEs (n=16, 44 %). Only 28 % (n=10) and 44 % (n=16) of the studies reported the analysis approach and statistical methods for AEs, respectively. A weak, non-significant positive correlation was found between ACS and year of publication (r = 0.288, p = 0.09). No study-level variable showed a statistically significant association with ACS. CONCLUSIONS:Reporting of OAEs in clinical trials of NCNPs remains limited and inconsistent, often lacking clear definitions, standardized severity assessments, detailed data collection methods, and predefined statistical plans. CLINICAL SIGNIFICANCE:Standardized OAE reporting is critical for tolerability data interpretation. We propose practical recommendations to guide researchers in improving the reporting of OAE and strengthening the role of dental professionals in supporting patients through smoking cessation strategies.