The effects of periodontal treatment on diabetic patients: The DIAPERIO randomized controlled trial.

AIM: To assess whether periodontal treatment can lead to clinical, glycaemic control and quality of life improvements in metabolically unbalanced diabetic patients (type 1 or type 2) diagnosed with periodontitis. METHODS: In this open-labelled randomized controlled trial, diabetic subjects (n = 91) were given "immediate" or "delayed" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral health instructions). The main outcome was the effect on glycated haemoglobin (HbA1C ) and fructosamine levels. The General Oral Health Assessment Index and the SF-36 index were used to assess quality of life (QoL). RESULTS: Periodontal health significantly improved after periodontal treatment (p < 0.001). Periodontal treatment seemed to be safe but had no significant effects on glycaemic control based on HbA1C (adjusted mean difference with a 95% confidence interval (aMD) of 0.04 [-0.16;0.24]) and fructosamine levels (aMD 5.0 [-10.2;20.2]). There was no obvious evidence of improvement in general QoL after periodontal treatment. However, there was significant improvement in oral health-related QoL (aMD 7.0 [2.4;11.6], p = 0.003). CONCLUSION: Although periodontal treatment showed no clinical effect on glycaemic control in this trial, important data were provided to support periodontal care among diabetic patients. Periodontal treatment is safe and improves oral health-related QoL in patients living with diabetes. ISRCTN15334496.

Discrete Distribution Based on Compound Sum to Model Dental Caries Count Data.

Methods for analysing dental caries and associated risk indicators have evolved considerably in recent decades. The use of zero-inflated or hurdle models is increasing so as to take account of the decayed, missing, and filled teeth (DMFT) distribution, which is positively skewed and has a high proportion of zero scores. However, there is a need to develop new statistical models that involve pragmatic biological considerations on dental caries in epidemiological surveys. In this paper, we show that the zero-inflated and the hurdle models can both be expressed as a compound sum. Using the same compound sum, we then present the generalized negative binomial (GNB) distribution for dental caries count data, and provide a numerical application using the data of the EPIPAP study. The GNB model generates the best score functions while handling the lifetime dental caries disease process better. In conclusion, the GNB model suits the nature of some count data, in particular when structural zeros are unlikely to occur and when several latent spells can lead to new countable events. For these reasons, the use of the GNB distribution appears to be relevant for the modelling of dental caries count data.

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.

Chronic estradiol treatment reduces platelet responses and protects mice from thromboembolism through the hematopoietic estrogen receptor α.

Although estrogens are known to have a deleterious effect on the venous thrombosis risk and a preventive action on the development of arterial atheroma, their effect on platelet function in vivo remains unclear. Here, we demonstrate that a chronic high physiologic level of estradiol (E2) in mice leads to a marked decrease in platelet responsiveness ex vivo and in vivo compared with ovariectomized controls. E2 treatment led to increased bleeding time and a resistance to thromboembolism. Hematopoietic chimera mice harboring a selective deletion of estrogen receptors (ERs) α or ß were used to demonstrate that the effects of E2 were exclusively because of hematopoietic ERα. Within ERα the activation function-1 domain was not required for resistance to thromboembolism, as was previously shown for atheroprotection. This domain is mandatory for E2-mediated reproductive function and suggests that this role is controlled independently. Differential proteomics indicated that E2 treatment modulated the expression of platelet proteins including ß1 tubulin and a few other proteins that may impact platelet production and activation. Overall, these data demonstrate a previously unrecognized role for E2 in regulating the platelet proteome and platelet function, and point to new potential antithrombotic and vasculoprotective therapeutic strategies.

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.

[Perceived oral health and use of dental services during pregnancy: the MaterniDent study]. / Santé bucco-dentaire perçue et recours aux soins pendant la grossesse : étude MaterniDent.

INTRODUCTION: The main objective of the MaterniDent study was to determine the nature and frequency of dental problems experienced by pregnant women and their associated factors. The secondary objective was to determine the frequency of dental visits during pregnancy and to identify associated factors. METHODS: The MaterniDent study was a multicenter cross-sectional study conducted among 904 postpartum women in three French maternity wards. Data were collected using self-administered questionnaires. Measured variables included socio-demographic, health and behavioral characteristics. RESULTS: 57% of women reported having experienced at least one dental problem during pregnancy, while 20% had experienced dental pain during pregnancy. Multiparity, vomiting, soda consumption and increased sugar consumption during pregnancy were significantly associated with dental pain (p<0.05). 56% of women did not visit a dentist during pregnancy, 26% consulted a dentist for a perceived problem, and 18% visited a dentist for a check-up. Younger pregnant women and those without supplemental insurance were less likely to see a dentist for a preventive dental visit (p <0.05). DISCUSSION: A significant proportion of women experienced a dental problem during pregnancy, although they did not necessarily consult a dentist to treat the problem. Given the impact of oral diseases for both mother and child, prevention and professional dental care during pregnancy should be promoted.

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.

Maternal dental caries and pre-term birth: results from the EPIPAP study.

OBJECTIVE. The aim of this study was to analyse the association between maternal dental caries and pre-term birth (PTB), with a particular focus on the infection-suspected causes of pre-term births. MATERIALS AND METHODS. A secondary analysis was performed on data from the EPIPAP study, a French multi-centre case-control study. Cases were 1107 women giving birth to a singleton live-born infant before 37 weeks of gestation and controls were 1094 women delivering at 37 weeks or more. A sub-group of cases was defined as women with spontaneous labour and/or pre-term premature rupture of membranes (PPROM, n = 620). A full-mouth dental examination was performed after delivery. The main factor of interest was the presence of decay on at least one tooth. RESULTS. Crude associations between presence of tooth decay and PTB or spontaneous PTB/PPROM were significant (OR = 1.21 [1.01-1.45] and OR = 1.25 [1.01-1.55], respectively). After adjustment for two sets of potential confounders (four pre-term birth risk factors and four social characteristics), for periodontitis status and for inter-examiner variability, tooth decay was not significantly associated with either PTB or spontaneous PTB/PPROM (aOR = 1.10 [0.91-1.32] and aOR = 1.14 [0.91-1.42], respectively). CONCLUSIONS. This study failed to demonstrate a significant association between tooth decay and pre-term birth. However, future well-designed studies are needed to further assess the link between dental caries and adverse pregnancy outcomes.

Metabolic syndrome, insulin resistance, and periodontitis: a cross-sectional study in a middle-aged French population.

AIM: Metabolic syndrome consists of a cluster of clinical and biological abnormalities, influenced by insulin resistance and promoting cardiovascular diseases. We examined the relationships between metabolic syndrome, its various components, insulin resistance, and periodontitis. MATERIALS AND METHODS: The study included 276 subjects (35-74 years) recruited within a cross-sectional survey on cardiovascular risk factors. Twenty-one were excluded because of infectious risk or total tooth loss. Clinical attachment loss (CAL), probing pocket depth (PD), gingival and plaque indexes were recorded. Periodontitis was classified into moderate and severe forms. RESULTS: The mean age was 58, 41% of the subjects had moderate and 39% had severe periodontitis. In univariate comparisons, periodontitis was associated with metabolic syndrome (p=0.050), most of its components, and HOMA index (homoeostasis model assessment of insulin resistance). After adjustment for confounders, only HOMA index remained associated with severe periodontitis (odds ratio [OR]=3.97 [95% confidence interval: 1.22-12.9], OR=3.78 [1.14-12.5] for third and fourth versus the first quartile of the HOMA index, respectively). The HOMA index was also associated with the number of periodontal sites with CAL>or=4 mm, CAL>or=5 mm, or PD>or=4 mm (greater number for higher HOMA-index values). This relationship disappeared in never-smokers. CONCLUSIONS: Our data support the relationships between metabolic disturbances and periodontitis, with a central role of insulin resistance.

Maternal periodontitis and the causes of preterm birth: the case-control Epipap study.

AIM: To analyse the association between maternal periodontitis and preterm birth (<37 weeks' gestation) according to the causes of preterm birth. MATERIALS AND METHODS: Epipap is a case-control multi-centre study of singleton livebirths. One thousand one hundred and eight women with preterm deliveries and 1094 with deliveries at term (> or =37 weeks) at six French maternity units were included. Periodontal examinations after delivery identified localized and generalized periodontitis. Cases were classified according to four causes of preterm birth. Polytomous logistic regression analysis was used to control for confounders (maternal age, parity, nationality, educational level, marital status, employment during pregnancy, body mass index before pregnancy, smoking status) and the examiner. RESULTS: Localized periodontitis was identified in 129 (11.6%) cases and in 118 (10.8%) control women and generalized periodontitis in 148 (13.4%) and 118 (10.8%), respectively. A significant association was observed between generalized periodontitis and induced preterm birth for pre-eclampsia [adjusted odds ratio 2.46 [95% confidence intervals (95% CI)1.58-3.83]. Periodontitis was not associated with spontaneous preterm birth or preterm premature rupture of membranes or with the other causes. CONCLUSION: Maternal periodontitis is associated with an increased risk of induced preterm birth due to pre-eclampsia.

Periodontal diseases and cardiovascular events: meta-analysis of observational studies.

OBJECTIVE: Many studies have investigated the relationship between periodontal and cardiovascular diseases but their results are heterogeneous. Meta-analyses were conducted to examine the association between exposure to periodontitis and cardiovascular diseases. MATERIAL AND METHODS: Studies published between 1989 and 2007 were retrieved from seven databases. The included articles reported the results from observational studies (cohort, cross-sectional and case-control studies) and assessed the link between periodontal exposure and cardiovascular diseases as confirmed by one of the following criteria: diagnosed coronary artery disease, angina pectoris, acute myocardial infarction, mortality caused by cardiac pathology. The study characteristics were abstracted by independent researchers following a standardised protocol. The MOOSE guidelines for meta-analysis of observational studies were followed. RESULTS: From 215 epidemiological studies, 47 were observational, of which 29 articles could be combined by the meta-analysis methodology. The pooled odds ratio calculated from the 22 case-control and cross-sectional studies was 2.35 (95% CI [1.87; 2.96], p < 0.0001). The risk of developing cardiovascular disease was found to be significantly (34%) higher in subjects with periodontal disease compared to those without periodontal disease (pooled relative risk from the 7 cohort studies was 1.34 (95% CI [1.27; 1.42], p < 0.0001). CONCLUSIONS: It seems from observational studies that subjects with periodontal diseases have higher odds and higher risks of developing cardiovascular diseases but the reduction in the risk of cardiovascular events associated with the treatment of periodontitis remains to be investigated.

The effect of periodontal treatment on patients with rheumatoid arthritis: The ESPERA randomised controlled trial.

OBJECTIVES: To assess the effect of periodontal treatment on clinical and biochemical parameters of rheumatoid arthritis (RA) and quality of life (QoL) in patients with moderately active RA who were diagnosed with periodontitis. METHODS: In this open-label randomised controlled trial, RA subjects (n = 22) were allocated to "immediate" or "delayed" periodontal treatment (full-mouth non-surgical scaling and root planing, systemic antibiotics, and oral hygiene instructions). The main outcome was the 3-month change on the Disease Activity Score 28 based on the Erythrocyte Sedimentation Rate (DAS28-ESR). The Health Assessment Questionnaire and the General Oral Health Assessment Index were used to assess general and oral health QoL, respectively. RESULTS: Periodontal health significantly improved after periodontal treatment (P = 0.03). Periodontal treatment appeared to be safe but led to no significant effects on the DAS28-ESR (adjusted mean difference with 95% confidence interval (aMD) of -0.03 [-0.98; 0.92]). There was no evidence of improvement in the general QoL after periodontal treatment and no significant effect was found for the oral health QoL, despite a positive trend in the "psychological impacts" domain (aMD of 0.13 [-0.07; 0.33], P = 0.20). CONCLUSIONS: Although no clinical effect of periodontal treatment on RA was identified, this trial provides important data to support periodontal care in RA patients. Periodontal treatment is safe and reduces oral inflammation with a possible effect on oral health QoL. Since both periodontitis and RA are complex and multifactorial chronic diseases, it is likely that patient-centred approaches involving both oral health professionals and rheumatologists will contribute to optimal patient care. ISRCTN79186420.

Preterm low birth weight and maternal periodontal status: a meta-analysis.

OBJECTIVE: This study was undertaken to assess the effect of maternal periodontal disease on preterm delivery and/or birth of low-weight infants. STUDY DESIGN: We conducted a meta-analytic review of 5 medical databases (MEDLINE, EMBASE, LILACS, BIOSIS and PASCAL) for human observational studies linking preterm delivery and/or birth of low-weight infants to maternal periodontal disease. The MOOSE guidelines for meta-analysis of observational studies were followed. RESULTS: The literature search revealed 17 articles that met the inclusion criteria. Seven thousand one hundred fifty-one women participated in the studies, 1056 of whom delivered a preterm and/or low birthweight infant. The overall odds ratio was 2.83 (95% CI: 1.95-4.10, P < .0001). This pooled value needed to be interpreted cautiously because there appeared to be a clear trend for the better quality studies to be of lower association strength. CONCLUSION: These findings indicate a likely association, but it needs to be confirmed by large, well-designed, multicenter trials.

Ethical reflection in dentistry: first steps at the Faculty of Dental Surgery of Toulouse.

The goal of this work is to contribute to ethical reflection in the dental profession through the example of a survey of ethical reflection and ethical issues in dentistry conducted at the dental school of Toulouse. A written survey was given to the heads of departments and to the sixth-year students and also to the dental faculty at the hospital dental clinic in order to estimate their level of understanding and concern about these topics.

Isotypic antibody response to plaque anaerobes in periodontal disease.

BACKGROUND: It has been suggested that locally produced immunoglobulin (Ig)A could be more protective than IgG and that there could be a relationship between crevicular fluid-specific IgA levels and the onset of periodontal disease. This study was designed to investigate this hypothesis regarding specific immune responses towards 4 plaque anaerobes in gingival crevicular fluid and saliva from patients with periodontopathies and controls. METHODS: Gingival crevicular fluid (GCF) and whole saliva were collected from 35 adults with periodontitis and 24 periodontally healthy adults (controls). Antigens were extracted from Actinomyces actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum and used to set up specific enzyme-linked immunosorbent assay (ELISA) tests to assess IgA and IgG levels to these microorganisms in the fluids collected. RESULTS: The crevicular fluid of periodontitis patients contained significantly higher levels of IgG to the 4 microorganisms tested than that of controls (P < 10(-6) for all comparisons). IgA levels to the 4 bacteria were statistically significantly much higher in control crevicular fluid (P < 10(-7) for all comparisons). Controls also had statistically significantly higher levels of specific salivary IgA than patients (P < 0.02 for all comparisons). CONCLUSIONS: These data support the potentially protective role of specific IgA directed to oral microorganisms involved in the onset and development of periodontal disease.

Oral health status in outpatients with rheumatoid arthritis: the OSARA study.

BACKGROUND: Observational studies and clinical trials are increasingly highlighting significant associations between periodontitis (chronic, infectious, inflammatory disease affecting tooth supporting tissues) and rheumatoid arthritis (chronic systemic autoimmune disease). OBJECTIVE: The aim of the study was to describe the dental, periodontal and oral prosthetic status of outpatients with Rheumatoid Arthritis (RA). MATERIAL AND METHODS: The study was conducted from June 2010 to March 2011 in the Rheumatology Day Care Department of the University Teaching Hospital, Toulouse. Activity of the RA was defined according to disease activity score 28 (DAS28). 74 subjects with RA were included. Periodontal status was determined using measurements of pocket depth, bleeding on probing and attachment loss. Periodontal Epithelial Surface Area (PESA) and Periodontal Inflamed Surface Area (PISA) were calculated. RESULTS: The study population was 60.3 ± 11.9 years old with 75.7% women. 48.6% of the subjects had moderate RA (3.2 < DAS28 ≤ 5.1) and 22.2% high RA activity (DAS28 > 5.1); 93.2% were treated by biotherapy. The mean number of natural teeth was 18.9 ± 9.7. The mean number of teeth replaced by removable prostheses was 7.1 ± 10.5. The mean PISA was 291.9 mm(2) ± 348.7 and the PISA:PESA ratio was 33.2% ± 24.2. 94% of patients had periodontitis, which was moderate in 48% and severe in 46%. CONCLUSION: This study highlights the need for prevention and for adequate dental care to improve global and oral quality of life of subjects with rheumatoid arthritis. Given the frequency of periodontitis and some physiopathological hypotheses, clinical trials are needed to assess if periodontal treatment could improve RA biological and clinical parameters.

Effect of fixed orthodontic appliances on salivary microbial parameters at 6 months: a controlled observational study.

OBJECTIVE: The aim of this study was to assess the microbial changes in children with fixed orthodontic appliances compared with a control group of children without orthodontic treatment. MATERIAL AND METHODS: Ninety-five children, aged between 12 and 16 years, participated in this study. Forty-eight subjects were fitted with fixed orthodontic appliances and forty-seven were free of any such appliances. The follow-up was 6 months for all children. The association between orthodontic appliances and high levels of Streptococcus mutans and Lactobacillus spp was assessed with logistic regression models, taking age, sex, pH and buffer capacity into account. RESULTS: Differences at baseline between the two groups were not statistically significant. We found that wearing a fixed orthodontic appliance was associated with high levels of Streptococcus mutans and Lactobacillus spp (adjusted OR: 6.65, 95% CI [1.98-22.37]; 9.49, 95% CI [2.57-35.07], respectively), independently of other variables. CONCLUSION: The originality of the present epidemiological study was to evaluate the evolution of salivary microbial parameters in a population of children with fixed orthodontic appliances. Our results show an increase of Streptococcus mutans and Lactobacillus spp values during the follow-up. The whole dental workforce should be aware that preventive measures are of paramount importance during orthodontic treatment.

Comparison of the accuracy of 3-dimensional cone-beam computed tomography and micro-computed tomography reconstructions by using different voxel sizes.

INTRODUCTION: Cone-beam computed tomography (CBCT) data are, in principle, metrically exact. However, clinicians need to consider the precision of measurements of dental morphology as well as other hard tissue structures. CBCT spatial resolution, and thus image reconstruction quality, is restricted by the acquisition voxel size. The aim of this study was to assess geometric discrepancies among 3-dimensional CBCT reconstructions relative to the micro-CT reference. METHODS: A total of 37 permanent teeth from 9 mandibles were scanned with CBCT 9500 and 9000 3D and micro-CT. After semiautomatic segmentation, reconstructions were obtained from CBCT acquisitions (voxel sizes 76, 200, and 300 µm) and from micro-CT (voxel size 41 µm). All reconstructions were positioned in the same plane by image registration. The topography of the geometric discrepancies was displayed by using a color map allowing the maximum differences to be located. RESULTS: The maximum differences were mainly found at the cervical margins and on the cusp tips or incisal edges. Geometric reconstruction discrepancies were significant at 300-µm resolution (P = .01, Wilcoxon test). CONCLUSIONS: To study hard tissue morphology, CBCT acquisitions require voxel sizes smaller than 300 µm. This experimental study will have to be complemented by studies in vivo that consider the conditions of clinical practice.

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.

BACKGROUND: Rheumatoid 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/DESIGN: The 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. DISCUSSION: Evidence-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 REGISTRATION: The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06.