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Biomechanical Informational Effect of Innovative Double or Triple Dental Abutment-implant: Case-series

NCT06127576 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-11-13

No results posted yet for this study

Summary

Objective: The aim of this case series study is to present the rationality and scientific evidence of a new design for a Double and Triple abutment with their specific new concept of Biodynamic Optimized Peri-implant Tissue (BOPiT).

Methods: The innovative design of these abutments with a paraboloid geometry was based on BOPiT, simultaneously involving the principles of mechanobiology, biotensegrity, and mechanotransduction. Thus, individuals rehabilitated with different extents of edentulous spaces using the innovative double and triple abutments on osseointegrated dental implants are included in this case series. The double and triple abutments support 2 or 3 dental crowns on a single implant, respectively. Clinic and radiographic examinations are presented at T1 (loading after 4 months of the implant insertion surgeries with the appropriate metalloceramic prostheses) and T2 \[final examination with a follow-up time ≥ 3 to 12 years (average of 7.2 years)\].

Conditions

  • Dental Implant

Interventions

DEVICE

paraboloid geometry double and triple dental abutment-implant

The implants were inserted with the margin between machined and micro-rough surface at bone level. The abutment and crowns were assembled and screw retained onto the implant with a torque of 35 Ncm. The implants were cylindrical with internal hexagon and without surface treatment, presenting 4.0 mm in diameter and length varying between 10 and 13 mm. Acording to the manual work model measurements, DA or TA acrylic individualized design and paraboloid surfaces of the DA (elliptical) and TA (hyperbolic) had been made.

Sponsors & Collaborators

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Fernando O Costa, PhD · Federal University of Minas Gerais

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2019-10-01
Completion
2023-10-01
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127576 on ClinicalTrials.gov