Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

<p>Abstract</p> <p>Background</p> <p>Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis.</p> <p>Methods</p> <p>The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups.</p> <p>Discussion</p> <p>The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN15334496</p

24-Month Clinical, Immuno-Virological Outcomes, and HIV Status Disclosure in Adolescents Living With Perinatally-Acquired HIV in the IeDEA-COHADO Cohort in Togo and Côte d'Ivoire, 2015-2017

Background: Adolescents living with perinatally-acquired HIV (APHIV) face challenges including HIV serostatus disclosure. We assessed their 24-month outcomes in relation to the disclosure of their own HIV serostatus. Methods: Nested within the International epidemiologic Database to Evaluate AIDS pediatric West African prospective cohort (IeDEA pWADA), the COHADO cohort included antiretroviral (ART)-treated APHIV aged 10-19 years, enrolled in HIV care before the age of 10 years, in Abidjan (Côte d'Ivoire) and Lomé (Togo) in 2015. We measured the HIV serostatus disclosure at baseline and after 24 months and analyzed its association with a favorable combined 24-month outcome using logistic regression. The 24-month combined clinical immuno-virological outcome was defined as unfavorable when either death, loss to follow-up, progression to WHO-AIDS stage, a decrease of CD4 count >10% compared to baseline, or a detectable viral load (VL > 50 copies/mL) occurred at 24 months. Results: Overall, 209 APHIV were included (51.6% = Abidjan, 54.5% = females). At inclusion, the median CD4 cell count was 521/mm (3) [IQR (281-757)]; 29.6% had a VL measurement, of whom, 3.2% were virologically suppressed. APHIV were younger in Lomé {median age: 12 years [interquartile range (IQR): 11-15]} compared to Abidjan [14 years (IQR: 12-15, p = 0.01)]. Full HIV-disclosure increased from 41.6% at inclusion to 74.1% after 24 months. After 24 months of follow-up, six (2.9%) died, eight (3.8%) were lost to follow-up, and four (1.9%) were transferred out. Overall, 73.7% did not progress to the WHO-AIDS stage, and 62.7% had a CD4 count above (±10%) of the baseline value (48.6% in Abidjan vs. 69.0% in Lomé, p 2 years compared to those who had not been disclosed to [aOR = 0.21, 95% CI (0.05-0.84), p = 0.03]. Conclusions: The frequency of HIV-disclosure improved over time and differed across countries but remained low among West African APHIV. Overall, the 24-month outcomes were poor. Disclosure before the study was a marker of a poor 24-month outcome in Lomé. Context-specific responses are urgently needed to improve adolescent care and reach the UNAIDS 90% target of virological success

HIV Status Disclosure and Retention in Care in HIV-Infected Adolescents on Antiretroviral Therapy (ART) in West Africa

We assessed the effect of HIV status disclosure on retention in care from initiation of antiretroviral therapy (ART) among HIV-infected children aged 10 years or more in Cote d'Ivoire, Mali and Sénégal.Multi-centre cohort study within five paediatric clinics participating in the IeDEA West Africa collaboration. HIV-infected patients were included in this study if they met the following inclusion criteria: aged 10-21 years while on ART; having initiated ART ≥ 200 days before the closure date of the clinic database; followed ≥ 15 days from ART initiation in clinics with ≥ 10 adolescents enrolled. Routine follow-up data were merged with those collected through a standardized ad hoc questionnaire on awareness of HIV status. Probability of retention (no death or loss-to-follow-up) was estimated with Kaplan-Meier method. Cox proportional hazard model with date of ART initiation as origin and a delayed entry at date of 10th birthday was used to identify factors associated with death or loss-to-follow-up.650 adolescents were available for this analysis. Characteristics at ART initiation were: median age of 10.4 years; median CD4 count of 224 cells/mm³ (47% with severe immunosuppression), 48% CDC stage C/WHO stage 3/4. The median follow-up on ART after the age of 10 was 23.3 months; 187 adolescents (28.8%) knew their HIV status. The overall probability of retention at 36 months after ART initiation was 74.6% (95% confidence interval [CI]: 70.5-79.0) and was higher for those disclosed compared to those not: adjusted hazard ratio for the risk of being death or loss-to-follow-up = 0.23 (95% CI: 0.13-0.39).About 2/3 of HIV-infected adolescents on ART were not aware of their HIV status in these ART clinics in West Africa but disclosed HIV status improved retention in care. The disclosure process should be thus systematically encouraged and organized in adolescent populations

Prophylactic antiretroviral regimens for prevention of mother-to-child transmission of HIV in resource-limited settings.

International audiencePURPOSE OF REVIEW: With the large international mobilization against HIV/AIDS, more HIV-infected people in resource-limited settings have access to antiretroviral therapy, including pregnant women. The relevance of simplified prophylactic antiretroviral regimens for the prevention of mother-to-child transmission of HIV may become questionable due to their lower efficacy and their higher risk of inducing viral resistance than fully suppressive antiretroviral therapy. RECENT FINDINGS: Field implementation of current recommendations, impact of prophylactic regimens on subsequent antiretroviral therapy response and possible new indications of antiretroviral therapy in pregnant women will be reviewed in this paper. SUMMARY: Prophylactic antiretroviral prevention of mother-to-child transmission regimens reached only 10% of the HIV-infected pregnant women in 2006, who were usually offered single-dose nevirapine only. The operational links between antenatal care and antiretroviral therapy programmes can now be documented and demonstrate good results in terms of safety and efficacy. The negative impact of single-dose nevirapine exposure on subsequent first-line antiretroviral therapy appears worse for mothers with advanced HIV disease at the time of delivery and short interval before antiretroviral therapy initiation. Strengthening the links between antenatal care and antiretroviral therapy programmes is critical for antiretroviral therapy-eligible HIV-infected pregnant women in terms of prevention of mother-to-child transmission and subsequent antiretroviral therapy response. The breastfeeding period could be a new indication for antiretroviral therapy in this population

Revue systématique des facteurs de risque modifiables des cancers de la muqueuse buccale

Les cancers de la cavité buccale (CCB) et des lèvres occupaient, en 2008, le 16ème rang des cancers dans le monde. Les principaux facteurs de risque connus de ces cancers sont le tabac et l’alcool mais il existe d’autres facteurs pouvant être ciblés dans le cadre d’une prévention primaire. L’objectif de cette étude était d’identifier les facteurs de risque évitables et les facteurs protecteurs des cancers de la muqueuse buccale à travers une revue systématique de la littérature scientifique récente. Les mots clés indexés dans le MeSH « risk factors » et « mouth neoplasms » ont été appliqués dans la base de données PubMed. Les articles publiés entre le 01/01/2005 et le 01/01/2011 en anglais et en français ont été retenus s’ils traitaient de CCB et d’un ou de plusieurs facteurs de risque. Les articles s’intéressant exclusivement aux cancers des glandes salivaires ou aux facteurs de risque génétiques, de même que les articles rapportant des études transversales ou de qualité insuffisante, ont été exclus. Sur 325 références, 32 ont été retenues : 19 études cas-témoins, 8 cohortes prospectives et 5 méta-analyses ; 2 études concernaient uniquement le cancer des lèvres. Les principaux facteurs de risque mis en évidence étaient la consommation d’alcool et de tabac et leur effet synergique. Des facteurs génétiques, comme le polymorphisme du gène codant pour l’alcool déshydrogénase ont été identifiés comme cofacteurs. Le HPV 16 impliqué dans la survenue du cancer du col de l’utérus pourrait avoir un rôle oncogène sur la muqueuse buccale. Des études ont identifié des facteurs locaux (traumatisme, mauvaise hygiéne…) mais elles ne sont pas apparues suffisamment fiables méthodologiquement pour pouvoir s’appuyer sur leurs conclusions. L’exposition aux ultra-violets a été mise en cause dans la survenue du cancer des lèvres, principalement chez les sujets transplantés. Une association entre CCB et exposition professionnelle importante aux pesticides et à certains solvants a également été retrouvée. Au contraire, une alimentation riche en fruits et légumes frais, la consommation de café et les visites régulières chez le chirurgien-dentiste étaient associées à une diminution du risque de CCB. Les CCB sont accessibles à une prévention primaire, axée aujourd’hui en France sur la lutte contre le tabagisme et la consommation d’alcool, qui s’intègre dans une démarche de santé publique plus globale car ces facteurs de risque sont communs à d’autres cancers et à d’autres maladies chroniques fréquentes. Dans cette logique, le programme de vaccination contre le HPV impliqué dans le cancer du col de l’utérus et le Programme National Nutrition Santé auront peut-être un effet favorable sur l’incidence des CCB. En ce qui concerne la prévention secondaire, le dépistage des lésions précancéreuses ou de lésions invasives à un stade précoce fait l’objet de mesures dans le Plan cancer gouvernemental 2009–2013

Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

International audienceAbstractBackgroundIrreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports major difficulties in achieving adequate analgesia to perform this emergency treatment, especially in the case of mandibular molars. In current practice, short-course, orally administered corticotherapy is used for the management of oral pain of inflammatory origin. The efficacy of intraosseous local steroid injections for irreversible pulpitis in mandibular molars has already been demonstrated but resulted in local comorbidities. Oral administration of short-course prednisolone is simple and safe but its efficacy to manage pain caused by irreversible pulpitis has not yet been demonstrated. This trial aims to evaluate the noninferiority of short-course, orally administered corticotherapy versus partial endodontic treatment for the emergency care of irreversible pulpitis in mandibular molars.Methods/designThis study is a noninferiority, open-label, randomized controlled clinical trial conducted at the Bordeaux University Hospital. One hundred and twenty subjects will be randomized in two 1:1 parallel arms: the intervention arm will receive one oral dose of prednisolone (1 mg/kg) during the emergency visit, followed by one morning dose each day for 3 days and the reference arm will receive partial endodontic treatment. Both groups will receive planned complete endodontic treatment 72 h after enrollment. The primary outcome is the proportion of patients with pain intensity below 5 on a Numeric Scale 24 h after the emergency visit. Secondary outcomes include comfort during care, the number of injected anesthetic cartridges when performing complete endodontic treatment, the number of antalgic drugs and the number of patients coming back for consultation after 72 h.DiscussionThis randomized trial will assess the ability of short-term corticotherapy to reduce pain in irreversible pulpitis as a simple and rapid alternative to partial endodontic treatment and to enable planning of endodontic treatment in optimal analgesic conditions.Trial registrationClinicalTrials.gov, identifier: NCT02629042. Registered on 7 December 2015.(Version n°1.1 28 July 2015