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Clinical Trials/NCT03018457
NCT03018457CompletedNot Applicable

Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country40 target enrollmentStarted: May 5, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Implant Stability Quotient (ISQ)

Study Overview

Brief Summary

Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.

This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).

The cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.

Detailed Description

The aim of this study is to check whether the trabecular bone with its microarchitecture plays a predictive role in osseointegration of dental implants precisely in its biological stability phase or its secondary stability phase.

If this correlation is established, a larger study must be conducted to identify a profile of patients at risk for failure of osseointegration of the dental implant.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • affiliated patient or entitled to a social security scheme
  • requiring the installation of one or more dental implants
  • partial or total loss teeth, the height and width od the alveolar bone does not require bone grafting or guides regeneration

Exclusion Criteria

  • patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary sinus, guided regeneration)
  • patient under corticosteroid therapy in the long term
  • patient who benefited from the head and neck radiotherapy
  • patient under bisphosphonates intravenously treatment
  • all cases immediate implantation and extraction of all implant put into immediate expenses

Outcomes

Primary Outcomes

Implant Stability Quotient (ISQ)

Time Frame: 10 weeks

The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.

Secondary Outcomes

  • degree of anisotropy(10 weeks)
  • trabecular number(10 weeks)
  • structural model index(10 weeks)
  • volume fraction of the bone(10 weeks)
  • trabecular separation(10 weeks)
  • connectivity density(10 weeks)
  • trabecular pattern factor(10 weeks)
  • thickness between trabecular(10 weeks)
  • Thickness of trabecular(10 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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