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

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ClinicalTrials.gov Identifier: NCT03018457
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Dental Implant Device: ISQ

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Group/Cohort Intervention/treatment
patients who need a dental implants Device: ISQ
Measured by Osstell.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. volume fraction of the bone [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  2. thickness between trabecular [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  3. Thickness of trabecular [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  4. trabecular separation [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  5. trabecular number [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  6. structural model index [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  7. trabecular pattern factor [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  8. connectivity density [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner

  9. degree of anisotropy [ Time Frame: 10 weeks ]
    Measured by Scanco microscanner



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who need a dental implant
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018457


Locations
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France
Cabinet dentaire MOLIMARD
Le Puy En Velay, France, 43000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Thierry THOMAS, MD PhD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03018457     History of Changes
Other Study ID Numbers: 1608111
ANSM ( Other Identifier: 2016-A01680-51 )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Trabecular microarchitecture
alveolar bone
osseointegration
dental implant