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

NCT ID: NCT03018457

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-05

Study Completion Date

2018-05-04

Brief Summary

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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

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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.

Conditions

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Dental Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who need a dental implants

ISQ

Intervention Type DEVICE

Measured by Osstell.

Interventions

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ISQ

Measured by Osstell.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry THOMAS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Cabinet dentaire MOLIMARD

Le Puy-en-Velay, , France

Site Status

Countries

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France

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1608111

Identifier Type: -

Identifier Source: org_study_id

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