The study is described as a double-blind trial (patients and outcome assessors). Surgeons and prosthodontists cannot be blinded, but radiologists perform measurements blindly. Operators do not communicate with the patient about the treatment to ensure independent radiologist measurements of ridge height and width.
The data will be analyzed by an independent statistician (HFC, in collaboration with the Henri Mondor Hospital Clinical Research Unit). The unit of analysis will be the extraction site (a maximum of six teeth will be extracted per patient). The demographic and clinical characteristics of the patients, the alveolar bone, and the extracted teeth will be described for both treatment arms with the usual statistics: mean and SD or median and interquartile ranges for quantitative variables and number of subjects and percentages for the qualitative variables [53]. The analyses will be performed according to the intent-to-treat principle.
prosthodontic treatment for edentulous patients 13th edition pdf free 48
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The trial received approval from the French Ethics Committee for the Protection of Persons (Comité de Protection de Personnes, trial number 13-019) in June 2013. The protocol is registered with the Agence Nationale pour la Sécurité du médicament et des Produits de Santé (ANSM, French National Agency for Medicines and Health Products Safety (2013-A00440-45 (IDRCB/Eudract)) and ClinicalTrials.gov (no. NCT02120053, 18 April 2014). All amendments to the protocol will be justified, submitted to the scientific board, accepted by the CPP, and recorded by the ANSM. Changes and amendments will be also recorded at ClinicalTrials.gov. Informed consent will be obtained from trial participants after the trial is explained by an investigator or operator of the corresponding center. Patients are informed that they have the right to withdraw from the study at any time without giving reasons. Regardless of withdrawal, patients will be provided any treatment in their best interest. Withdrawal will be documented. Data confidentiality was audited by the Comité National Informatique et Liberté (National Committee of Informatics and Freedom); last and first names of included patients are not recorded in the database. Moreover, the authors followed the SPIRIT 2013 checklist (Fig. 6).
Two surgical templates were made for each jaw. The first template was positioning the teeth-supported surgical template containing sleeves for drilling intraosseous holes for the placement of fixation pins. The localisation of these holes fully matches similarly in the second, full-guided surgical template attached on the edentulous jaw by fixation pins in the same intraosseous holes after extraction of all teeth. Thus, maximum accuracy of the full-guided template was achieved on working on edentulous jaws (Figure 3). The patient reviewed the treatment plan and signed the informed procedure agreement. 2ff7e9595c
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