Immediate placement delayed loading of a patient specific dental Implant; an essential experimental device exemption study

Not Applicable

• Conditions: Tooth Extraction; E04.545

• Registration Number: RBR-9hvrmz8
• Lead Sponsor: niversidade de São Paulo - Faculdade de Odontologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-15
• Last Update Posted: 18 September 2023
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified