Tooth Extraction
Conditions
Interventions
The study will be a multicenter, prospective, single arm (performance goal) pivotal IDE study on 128 subjects (32 in Brazil) requiring the removal of a single rooted tooth and replacement with a custo
Sponsors
Universidade de São Paulo - Faculdade de Odontologia
Atlantis Clinical Brazil LTDA
Eligibility
Age
22 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects 22 to 75 years of age. Both sexes. Subject indicated for single-rooted tooth or fused premolar roots atraumatic extraction with the intention for immediate implant placement that does not require bone augmentation (i.e., no lateral, vertical, or sinus augmentation required), the implant restoration will support a single-unit prosthetic restoration. Proposed implant sites should have intact cortical plates (at least 1 mm in thickness) and free of apical lesions or marginal bone loss. Implant sites with sufficient soft tissue quality, quantity, and morphology that do not require augmentation (thick phenotype). Subjects will have read, understood, and signed an institutional review board approved Informed Consent Form. Subjects must be able and willing to follow study procedures and instructions
Exclusion criteria
Exclusion criteria: Subjects with a history of tobacco use within the last two years. Subjects with healing disorders (such as: diabetes mellitus confirmed HgA1C of > 7 within six months prior to screening, cancer, HIV, bone metabolic diseases or Type IV heart disease) that could compromise wound healing and/or preclude implant surgery; or who are currently receiving, or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and/or preclude oral surgery. Subjects taking any bisphosphonates; Subjects taking hormone therapy or have had a hysterectomy. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). Subjects with proposed implant sites that demonstrate soft tissue recession or soft tissue deficiency that requires soft tissue augmentation. Subjects with untreated periodontal disease or other uncontrolled infections of the oral cavity. Subjects who have a bruxing or clenching habit. Subjects with insufficient oral hygiene (plaque score > 25%, bleeding on probing > 50% of sites). Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol. Subjects with cuspid protected occlusion, where full disclusion of all working side posterior teeth occurs in lateral movements. Subjects with other implant treatments currently in progress or who require replacement of additional teeth within the time frame of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant survival at 12 months post-loading (approximately 15 months post implantation). Implant survival rate is defined as the percentage of implants that do not show symptoms of mobility or significant infection; Lack of mobility is defined as Class 0 or Class 1 mobility as defined by the Miller Classification of Mobility (Miller 1938); Significant infection (as it impacts implant survival) refers to clinical signs and symptoms which require treatment and compromise the stability of the implant. Minor infections successfully treated and resolved will be reported as adverse events, but will not be defined as implant failures; Cumulative average marginal bone loss of all surviving implants at 12 months post-loading (baseline measurement established at time of implant loading in occlusion and final crown placement); Method of measurement: Changes in bone levels will be assessed by direct measurements on standardized, digital, periapical radiographs (adapted from Yoo et al., 2006) at 6 months and 12 months post-loading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Satisfaction; Method of measurement: Patient Reported Outcomes (PROs) for discomfort, esthetics and satisfaction, each ranked from 1-10; Clinician Satisfaction; Method of measurement: Clinician Satisfaction Questionnaires for time required, esthetics and ease of use, each ranked from 1-10. | — |
Countries
Brazil, United States
Contacts
Public ContactAndrea Martinez
Atlantis Clinical Brazil LTDA
Outcome results
None listed