Cathy Nabet

Ethics in systematic reviews

Since its introduction by the Nuremberg Code and the Declaration of Helsinki, the place held by ethics in biomedical research has been continuously increasing in importance. The past 30 years have also seen exponential growth in the number of biomedical articles published. A systematic review of the literature is the scientific way of synthesising a plethora of information, by exhaustively searching out and objectively analysing the studies dealing with a given issue. However, the question of ethics in systematic reviews is rarely touched upon. This could lead to some drawbacks, as systematic reviews may contain studies with ethical insufficiencies, may be a possible way to publish unethical research and may also be prone to conflict of interest. Finally, informed consent given for an original study is not necessarily still valid at the systematic review level. There is no doubt that routine ethical assessment in systematic reviews would help to improve the ethical and methodological quality of studies in general. However, ethical issues change so much with time and location, and are so broad in scope and in context that it appears illusory to search for a universal, internationally accepted standard for ethical assessment in systematic reviews. Some simple suggestions could nevertheless be drawn from the present reflection and are discussed in the paper.

Concise Review: Mesenchymal Stromal Cells Used for Periodontal Regeneration: A Systematic Review

Periodontitis is a chronic infectious disease of the soft and hard tissues supporting the teeth. Recent advances in regenerative medicine and stem cell biology have paved the way for periodontal tissue engineering. Mesenchymal stromal cells (MSCs) delivered in situ to periodontal defects may exert their effects at multiple levels, including neovascularization, immunomodulation, and tissue regeneration. This systematic review had two goals: (a) to objectively quantify key elements for efficacy and safety of MSCs used for periodontal regeneration and (b) to identify patterns in the existing literature to explain differences between studies and suggest recommendations for future research. This systematic review provided good evidence of the capacity of MSCs to regenerate periodontal tissues in animals; however, experimentally generated defects used in animal studies do not sufficiently mimic the pathophysiology of periodontitis in humans. Moreover, the safety of such interventions in humans still needs to be studied. There were marked differences between experimental and control groups that may be influenced by characteristics that are crucial to address before translation to human clinical trials. We suggest that the appropriate combination of cell source, carrier type, and biomolecules, as well as the inclusion of critical path issues for a given clinical case, should be further explored and refined before transitioning to clinical trials. Future studies should investigate periodontal regenerative procedures in animal models, including rodents, in which the defects generated are designed to more accurately reflect the inflammatory status of the host and the shift in their pathogenic microflora.

Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

BackgroundRheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA.Methods/designThe ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups.DiscussionEvidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients.Trial registrationThe ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.

Frequency and risk indicators of tooth decay among pregnant women in France: a cross-sectional analysis.

Introduction Little is known on the prevalence of tooth decay among pregnant women. Better knowledge of tooth decay risk indicators during pregnancy could help to develop follow-up protocols for women at risk, along with better prevention strategies. The aim of this study was to assess the frequency of tooth decay and the number of decayed teeth per woman in a large sample of pregnant women in France, and to study associated risk indicators. Methods A secondary cross-sectional analysis of data from a French multicentre case-control study was performed. The sample was composed of 1094 at-term women of six maternity units. A dental examination was carried out within 2 to 4 days post-partum. Socio-demographic and behavioural characteristics were obtained through a standardised interview with the women. Medical characteristics were obtained from the women’s medical records. Risk indicators associated with tooth decay were identified using a negative binomial hurdle model. Results 51.6% of the women had tooth decay. The mean number of decayed teeth among women having at least one was 3.1 (s.d. = 2.8). Having tooth decay was statistically associated with lower age (aOR = 1.58, 95%CI [1.03,2.45]), lower educational level (aOR = 1.53, 95%CI [1.06,2.23]) and dental plaque (aOR = 1.75, 95%CI [1.27,2.41]). The number of decayed teeth was associated with the same risk indicators and with non-French nationality and inadequate prenatal care. Discussion The frequency of tooth decay and the number of decayed teeth among pregnant women were high. Oral health promotion programmes must continue to inform women and care providers about the importance of dental care before, during and after pregnancy. Future research should also assess the effectiveness of public policies related to oral health in target populations of pregnant women facing challenging social or economic situations.

Oral health-related quality of life among outpatients with rheumatoid arthritis

OBJECTIVES The aims of the Oral Status And Rheumatoid Arthritis (OSARA) cross-sectional study were to study the oral health-related quality of life and to assess the associated factors in a population of outpatients with rheumatoid arthritis in France. METHODS The data were collected by five trained and standardised dentists who asked each subject the questions of a socio-demographic, behavioural and medical questionnaire, which was completed with the medical records, and performed the dental examination. Each subject filled out two self-assessment questionnaires: the Health Assessment Questionnaire and the General Oral Health Assessment Index. RESULTS Seventy-three subjects were included. The mean age of the participants was 60.2 ± 11.9 years and 75.3% were women. For 58.3% of the subjects, their self-perceived oral health-related quality of life was described as poor. The logistic regression analysis found that a small number of teeth and marked difficulties in dressing and grooming were associated with bad oral health-related quality of life [ORa = 10.5 (1.96-56.19) and ORa = 4.3 (1.15-15.77), respectively]. CONCLUSIONS More care should be given to the prevention of dental diseases in order to improve the oral health-related quality of life of patients with rheumatoid arthritis and their self-esteem, which will already be heavily affected.

Clinical research activity in periodontal medicine: a systematic mapping of trial registers.

AIM The primary aim of the study was to systematically map registration records on periodontal medicine in clinical trial registers. The secondary aim was to assess the evolution of periodontal medicine in clinical periodontal research as a whole. MATERIAL AND METHODS We searched all registration records related to periodontology in the World Health Organization International Clinical Trials Registry Platform. For registration records classified in the field of periodontal medicine, we assigned the 2015 MeSH(®) term for the most precisely corresponding systemic condition. RESULTS Fifty-seven systemic conditions have been hypothesized to be linked with periodontal diseases, covering nearly 2% of the diseases indexed in MeSH. In addition to diabetes, cardiovascular disease or preterm birth, other systemic conditions have been the subject of registration records, such as anaemia, liver diseases, dyspepsia or ankylosing spondylitis. A trend towards increasing diversification of systemic conditions has appeared over time. About a third of registration records in clinical periodontal research deals with periodontal medicine. CONCLUSIONS Periodontal medicine now constitutes an important part of clinical periodontal research. Research activity in periodontal medicine has grown continuously since the early 2000s, and exploration of registers gives a useful up-to-date snapshot of this constantly evolving field of research.

Impact of periodontitis definition in epidemiological research. Results from the EPIPAP study in postpartum women.

The purpose of this investigation was to study the impact of using various definitions of periodontitis on the frequency of periodontitis and on the associations with some known risk factors for periodontitis in a population of postpartum women in France. A clinical examination was performed within 2-4 d postpartum in 932 at-term women at five maternity units. We studied six definitions of periodontitis; five were applicable if at least two teeth were found to have the following: (i) a proximal clinical attachment level (CAL) of ≥ 3 mm; (ii) a probing depth (PD) of ≥ 4 mm; (iii) a PD of ≥ 4 mm and a CAL of ≥ 3 mm at the same site; (iv) a proximal PD of ≥ 5 mm or a proximal CAL of ≥ 4 mm; or (v) a PD of ≥ 4 mm and a CAL ≥ 3 mm and bleeding on probing at the same site. The sixth definition required the involvement of four teeth with a PD of ≥ 4 mm and a CAL of ≥ 3 mm at the same site. Associations between case status according to each definition and maternal characteristics (age, educational level, smoking before pregnancy, and time since last dental visit) were analyzed using generalized estimating equation models. The definition of periodontitis had an impact on the frequency of periodontitis, which ranged from 12.1% to 37.7%, and produced different ORs for the associations with risk factors for periodontitis.

Early risk factors for posterior crossbite and anterior open bite in the primary dentition

OBJECTIVE To investigate risk factors specific to posterior crossbite and anterior open bite at the age of 3 years. MATERIALS AND METHODS The study included 422 children of the French EDEN mother-child cohort. The main outcomes were the presence of posterior crossbite and anterior open bite assessed by dentists at 3 years. Social characteristics (collected during pregnancy), neonatal characteristics (collected at birth), duration of breast-feeding (collected prospectively), sucking habits at 3 years, and open lips (as a proxy for mouth breathing) were studied and two logistic regressions conducted. RESULTS Preterm birth appears to be a risk factor specific for posterior crossbite (OR: 3.13; 95% CI: 1.13-8.68), whereas small for gestational age seems to be associated with a lower risk of posterior crossbite (OR: 0.32; 95% CI: 0.12-0.87). Ongoing pacifier or thumb sucking at 3 years is a risk factor for both posterior crossbite and anterior open bite. CONCLUSIONS Children born preterm seem to be more at risk for posterior crossbite than those born at term. Different mechanisms may be involved in posterior crossbite and anterior open bite.

Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.

BackgroundDental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis.MethodsThe CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument’s items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials.DiscussionFor clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for inlay/onlay restoration. For patients, the results may lead to improvement in long-term restoration. For researchers, the results may provide ideas for further research concerning inlay/onlay materials and prognosis.This trial is funded by a grant from the French Ministry of Health.Trial registrationClinicalTrials.gov Identifier:NCT01724827

Socioeconomic and behavioral determinants of tooth brushing frequency: results from the representative French 2010 HBSC cross‐sectional study

OBJECTIVES To describe tooth brushing frequency and its association with a wide range of socioeconomic and behavioral characteristics, using a nationally representative sample of school-aged children in France. METHODS Our sample included 11,337 students aged from 10 to 16 years, who answered the HBSC questionnaire. Some variables were grouped into composite variables, thus generating scores for: eating habits, health and body, relationships with parents, socioeconomic status (SES) of family, and school life. Multivariate logistic regression analyses were used to study the relationship between these variables and tooth brushing frequency. RESULTS Girls were more likely to brush twice a day than boys [adjusted Odds Ratio: aOR 2.47, 95 percent confidence interval CI95% (1.97; 3.11), aOR 1.89, CI95% (1.56; 2.29), aOR 1.45, CI95% (1.25; 1.68) for low, mid, and high school life score, respectively]. Students were more likely to brush twice a day when they had high (versus low) scores for healthy eating habits [aOR = 1.60; 95 percent CI: (1.40; 1.83)], well-being concerning health and body [aOR = 1.61; 95 percent CI: (1.40; 1.86)] and SES [aOR = 1.25; 95 percent CI: (1.09; 1.43)]. CONCLUSIONS We believe that preventive health campaigns should target school and family environments more specifically to reach the most disadvantaged sections of the population and include promotion of whole health. The messages should be designed to efficiently reach adolescents, e.g., by appealing to their maturity, self-esteem, and emotional factors. Through the incorporation of qualitative research elements, identifying the reasons for not brushing twice a day would also help to develop new prevention programs.