Influence of sleeve type, diameter, handle, site, and operator on the positioning accuracy of implants installed by computer-guided static surgery - Randomized controlled clinical trial

• Grant number: 22/15361-8
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: March 01, 2024
• End date: January 31, 2026
• Field of knowledge: Health Sciences - Dentistry - Dental Materials
• Principal Investigator: Guilherme de Siqueira Ferreira Anzaloni Saavedra
• Grantee: Tatiana Cursino Pereira
• Host Institution: Instituto de Ciência e Tecnologia (ICT). Universidade Estadual Paulista (UNESP). Campus de São José dos Campos. São José dos Campos , SP, Brazil

Abstract

The objective of this study is to analyze the influence that certain factors have on the accuracy of the positioning of an implant installed through computer-guided static surgery.The first outcome will be in relation to the steps of the procedure through the digital flow. The secondary outcome will be on the cost-effectiveness of the technique. For the analysis of the factors mentioned above to be possible, the accuracy of the implant positioning will be evaluated in relation to its virtual planning. Computed tomography (used in case planning) will be superimposed on STL files obtained by intraoral scanning (prior to surgery and after 6 months of device installation surgery). In this analysis, the accuracy will be measured by the deviation between the virtual plan and the actual position of the implant. The following deviations will be calculated: Global angular deviation; Coronal deviation; Apical deviation; Depth deviation. 60 volunteers will be selected, between 18 and 75 years old, who present the need for rehabilitation with the implant of at least one tooth, either anterior or posterior. The project will be submitted to the research ethics committee.Patients will be divided into their respective groups, according to the inclusion criteria of each factor that will be analyzed. That is, for analysis of the implant installation site, patients will be divided into: Group I: Patients with rehabilitation in the maxilla; Group II: Patients with rehabilitation in the mandible. And for the evaluation between the anterior and posterior regions, the following groups will be adopted: Group A: Patients with rehabilitation in the anterior region; Group B: Patients with rehabilitation in the posterior region. The number of patients per group will be 20, with 40 being the total number of the sample, already considering possible sample losses during the execution of the study. In the first consultation, patients will undergo anamnesis, clinical examination, intraoral scanning and will receive a request for cone beam computed tomography. With these data, the operator will carry out the virtual planning of the case, as well as make the model and the surgical guide printed by the additive method. The patient will return for surgery to install the implant(s), which will be followed up after 7 days. Finally, after osseointegration, about 6 months, a new intraoral scan will be performed and the data will be analyzed in software. The accuracy will be determined as the difference between the actual position and the planned position in each of the samples (n=40). Analysis of variance (ANOVA) will be conducted to assess the statistical significance of differences between different groups, with p<0.05.