Effectiveness of oral prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a non inferiority randomized clinical trial. - PULPISOLONE

CHU de Bordeaux0 个研究点目标入组 120 人开始时间: 2015年6月24日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•Participants will be included if they meet the following inclusion criteria:
•-clinical signs of irreversible pulpitis on a mandibular molar,
•-ASA1 or ASA2 score (American Society of Anesthesiologists)
•-Age between 18 and 70 years (of either gender)
•-Ability to give written informed consent
•-Affiliation to a health insurance scheme
•-Agreement to be contacted by phone 24h after the emergency visit
•-Availability to come back 72 hours after the emergency visit for complete endodontic treatment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Participants will be excluded if they present at least one of the following exclusion criteria:
•-diagnosis of reversible pulpitis , acute apical periodontitis, periodontal lesion of endodontic origin or dentin syndrome
•-not retainable tooth requiring extraction
•-contraindication of endodontic treatment (endocarditis risk),
•-contraindication for the prescription of glucocorticoids or codeine,
•-viral disease in evolution (hepatitis, herpes zoster, .. ),
•-machine operators ,
•-psychosis uncontrolled by treatment,
•-allergy to one or more of the components,
•-diabetes, drug intake with direct interaction with glucocorticoids or codeine,
•-woman of child-bearing age without contraceptive, pregnancy, breastfeeding
•-not able to give informed consent,
•-participating in another interventional study.

发起方

CHU de Bordeaux