Effect of Lactobacillus reuteri on Gingival Inflammation and Composition of the Oral Microbiota in Patients Undergoing Treatment with Fixed Orthodontic Appliances: Study Protocol of a Randomized Control Trial
2022
Agossa, K. | Dubar, M. | Lemaire, G. | Blaizot, A. | Catteau, C. | Bocquet, E. | Nawrocki, L. | Boyer, Emile | Meuric, V. | Siepmann, F. | Médicaments et biomatériaux à libération contrôlée: mécanismes et optimisation - Advanced Drug Delivery Systems - U 1008 (MBLC - ADDS) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille) | Centre Hospitalier Régional Universitaire [CHU Lille] (CHRU Lille) | Institut de recherche sur le cancer ; Institut National de la Santé et de la Recherche Médicale (INSERM) | Université de Lille | Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou] | Nutrition, Métabolismes et Cancer (NuMeCan) ; Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | The study will be supported by a Grant from Sunstar.
International audience
Afficher plus [+] Moins [-]anglais. The effect of probiotics in improving or maintaining oral health in orthodontic patients is understudied. The aim of this study is to evaluate the effect of probiotic administration in addition to tooth brushing on clinical gingival inflammation, plaque formation, subgingival microbiota composition, and salivary biomarkers of inflammation in adolescents with fixed orthodontic appliances. The present study is a 6-month, double-blind, two-arm, placebo-controlled, single-center trial, in which 116 adolescent volunteers aged 12–16 years will be recruited from the patients of the orthodontics clinic of the University Hospital of Lille, France. Subjects who meet the eligibility criteria will be allocated to one of the following groups: (i) control: two placebo lozenges per day for 90 days together with regular oral hygiene, (ii) test: two probiotic lozenges per day for 90 days together with regular oral hygiene. Clinical assessment and biological sample collection will be performed at baseline, 3 and 6 months. In addition, compliance outcomes and adverse events will be monitored. © 2022 by the authors. Licensee MDPI, Basel, Switzerland.
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