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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Le Puy En Velay, France, 43000
    • Cabinet dentaire MOLIMARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who need a dental implant

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Stability Quotient (ISQ)	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume fraction of the bone	Measured by Scanco microscanner	10 weeks
thickness between trabecular	Measured by Scanco microscanner	10 weeks
Thickness of trabecular	Measured by Scanco microscanner	10 weeks
trabecular separation	Measured by Scanco microscanner	10 weeks
trabecular number	Measured by Scanco microscanner	10 weeks
structural model index	Measured by Scanco microscanner	10 weeks
trabecular pattern factor	Measured by Scanco microscanner	10 weeks
connectivity density	Measured by Scanco microscanner	10 weeks
degree of anisotropy	Measured by Scanco microscanner	10 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thierry THOMAS, MD PhD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2017
• Primary Completion (ACTUAL): May 4, 2018
• Study Completion (ACTUAL): May 4, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (ESTIMATE): January 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: dental implant; osseointegration; alveolar bone; Trabecular microarchitecture
• Other Study ID Numbers: 1608111; ANSM (Other Identifier: 2022-A00796-37)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO