Bone Evaluation of Dental Implants Produced by 3D Printing in Mandible or Maxilla: clinical study

Not Applicable

• Conditions: oss of teeth due to accident, extraction or localized periodontal diseases

• Registration Number: RBR-9sjh5rm
• 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: 2022-11-25
• Last Update Posted: 29 May 2023
• Study Completion: 2023-11-01

Recruitment & Eligibility

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

Inclusion Criteria

Patients who are a minimum age of 18 years and a maximum of 70 years; with good general health; who have signed the Informed Consent Form; in need of rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars); with bacterial plaque index = 20%; bleeding rate = 20%; sufficient alveolar bone volume for an implant of 8 or 10mm length, diameter of 3.5mm, 4.00mm or 4.5mm, with bone quality type I-III and no associated bone regeneration required

Exclusion Criteria

Pregnant and lactating women; uncontrolled diabetes; history of chemotherapy or radiotherapy in the last 5 years; radiation therapy to areas of the head and neck; use of immunosuppressants, bisphosphonates or prolonged use of corticosteroids; smokers; alcohol or drug abuse; untreated periodontitis; history of previous bone augmentate in the implant installation region; presence of residual roots at the site to receive the implant; type IV bone density; individuals with connective tissue disorders or bone metabolic diseases; postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism; need for guided bone regeneration at the time of implant placement

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this study will be to evaluate the non-inferiority of implants produced by additive manufacturing loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up.

Secondary Outcome Measures

Name	Time	Method
Evaluate implant success rate, plaque index, peri-implant bleeding index, clinical probing depth, clinical level of insertion over 1 year after placement.