Clinical trial NCT03018457: Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant
Keywords: Trabecular microarchitecture
alveolar bone
osseointegration
dental implant
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need a dental implant

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.

Eligibility 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

Primary outcomes:
measure: Implant Stability Quotient (ISQ)
timeFrame: 10 weeks
Secondary outcomes:
measure: volume fraction of the bone
timeFrame: 10 weeks
measure: thickness between trabecular
timeFrame: 10 weeks
measure: Thickness of trabecular
timeFrame: 10 weeks
measure: trabecular separation
timeFrame: 10 weeks
measure: trabecular number
timeFrame: 10 weeks
measure: structural model index
timeFrame: 10 weeks
measure: trabecular pattern factor
timeFrame: 10 weeks
measure: connectivity density
timeFrame: 10 weeks
measure: degree of anisotropy
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Le Puy En Velay
country: France
facility: Cabinet dentaire MOLIMARD
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thierry THOMAS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: