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Consequently, many patients are not eligible. Generally, the two types of trials provide similar results, but estimates of the treatment effect may differ between split-mouth and parallel-arm RCTs.13�C15 Therefore, we chose to conduct a split-mouth RCT and a parallel-arm RCT. Methods Study setting Patients will be included and treated in the Department of Paediatric Dentistry at three University dental hospitals in France: Rennes, Nice and Bretonneau Hospital in Paris. Eligible criteria The inclusion criteria are (1) patients 7�C15?years old; (2) absence of disease (handicap, autism, cancer, heart disease, sickle cell anaemia); (3) no analgaesic drug use 48?h before randomisation; (4) preserved pulp vitality as determined by clinical and radiographic observations and (5) agreement by patient and parents, or guardians, to participate in the study. Patients with periodontal disease (periodontal pockets or dental mobility) or radiological defects (necrosis, furcation or periapical radiolucency) are not eligible. Treatments concern first permanent molars with deep caries (ie, dentinal lesion involving more than 50% of the entire dentine thickness evaluated by radiographs) or MIH (moderate-to-high severity) and can be conservative or endodontic limited to pulpotomy. Patients and parents/guardians will receive explanations of the two anaesthesia techniques, and anaesthesia will be performed after they provide oral informed consent (see online supplementary files, texts S1�CS4). Each patient will undergo two anaesthesia techniques: conventional, and intraosseous with the QuickSleeper system (hereafter intraosseous anaesthesia). The two anaesthesia types will be performed by the same dentist (one of the four authors). For the split-mouth RCT, eligible patients will receive the anaesthesia treatment on at least two first permanent molars belonging to the same dental arch. Each patient will undergo treatment of a tooth with one of the techniques, and treatment of the homologous contralateral tooth with the other technique. A 7�C21?day interval is allowed between one procedure and the other. For the parallel-arm RCT, eligible patients will require treatment with anaesthesia in one first permanent molar. Each patient will be Selleckchem GS-1101 allocated to receive one or the other technique. Interventions The topical anaesthesia Xyloca?ne visqueuse 2% (AstraZeneca, Rueil Malmaison, France) will be applied for 1�C2?min on previously dried mucosa before both anaesthesia techniques. Conventional anaesthesia, that is, para-apical maxillary and locoregional mandibular anaesthesia, will involve use of 16 and 35?mm long needles, respectively. Intraosseous anaesthesia will be administered by the QuickSleeper system (Dental Hi Tec, Cholet, France) following the instructions of the manufacturer.16 A 30-gauge, 9 or 13?mm long needle will be used.