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NCT Number: NCT03018457

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet dentaire MOLIMARD

Le Puy-en-Velay, 43000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISQ

Device

Measured by Osstell.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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