Lack of attention to sex and gender in periodontitis‐related randomized clinical trials: A meta‐research study

Abstract

Aim This meta‐research study aimed to investigate the level of compliance with the Sex and Gender Equity in Research (SAGER) Guidelines for the inclusion, analysis, and reporting of sex/gender, in periodontitis‐related randomized controlled trials (RCTs). Materials and Methods Following the inclusion of RCTs related to the treatment of periodontitis published between 2018 and 2019, we applied the SAGER checklist to assess the adherence to sex/gender reporting guidelines. We used non‐parametric descriptive statistics and correlation models to test the association of the dependent outcome with other variables. Results One hundred and one articles were included in the analysis. The female enrolment ranged between 30% and 94%. Twenty‐six studies enrolled less than 50% of female participants. The overall SAGER score (OSS) of item fulfilment ranged between 0 and 7 items with an average of 1.9 items signifying poor guideline adherence to the SAGER guidelines. These findings were not associated with the corresponding author gender (p = .623), publication year (p = .947), and funding source (p = .133). However, a significant but negative correlation with journal impact factor (r = −0.253, p = .026) was observed. Conclusions Sex and gender were frequently disregarded in clinical trial reporting. This oversight might limit the understanding of sex/gender differences in periodontitis‐related clinical trials.

Periodontitis‐resistant and ‐susceptible matriline regulation of gingival transcriptome in nonhuman primates

“…Previous studies in humans have tended to emphasize age as a dominant demographic modifier of periodontitis prevalence and extent/severity. 26,[57][58][59][60] However, these data support a likely crucial component of heritability (e.g., genetics) in the features of the gingival responses to the altered microbial burden associated with periodontal lesions. We have shown in similar analysis that sex of these animals combined with kinetics of the lesion also substantially dictates the local gingival tissue responses, with a lower effect of age on these outcomes.…”

“…Further evaluation highlighted clusters reflecting the stage of health, disease, or resolution of the experimental model, with less discriminatory impact of age of the animals. Previous studies in humans have tended to emphasize age as a dominant demographic modifier of periodontitis prevalence and extent/severity 26,57–60 . However, these data support a likely crucial component of heritability (e.g., genetics) in the features of the gingival responses to the altered microbial burden associated with periodontal lesions.…”

Sex effects on gingival transcriptomic patterns during initiation, progression, and resolution of periodontitis

“…40 A Journal of the American Dental Association (JADA) article in 2002 41 concluded that more sex-specific research is required to understand some unique features of oral disease in women related to adverse pregnancy outcomes, cardiovascular disease, and osteoporosis, as examples. A recent report emphasizes that now 2 decades later, 42 sex and gender are often disregarded in clinical trials of periodontitis and, thus, there still remain large gaps in our understanding of the unique mechanisms related to onset and progression of periodontitis between the sexes.…”

Multiplicative effect of stress and poor sleep quality on periodontitis: A university‐based cross‐sectional study

“…Furthermore, after assumptions verification, multiple linear regression models were built to evaluate the association between perceived stress and sleep quality with additional periodontal variables, that is, mean CAL, and mean PPD. The multiple models were adjusted for age, 30,31 body mass index, 32 sex, 33 smoking, 34 education, 35,36 toothbrushing frequency, 37 and comorbidities (binary variable defined as the presence of at least one comorbidity among those mentioned above), a priori selected according previous evidence of their association with the exposure, the outcome, or both. 38 Results from regression analyses were expressed as odds ratios (ORs) or beta coefficient (β) with 95% CI.…”