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

Dental Implant Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018457
• Other study ID #: 1608111
• Secondary ID: ANSM
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: May 4, 2018

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant

Intervention

Device:
• ISQ
Measured by Osstell.

Locations

Country	Name	City	State
France	Cabinet dentaire MOLIMARD	Le Puy En Velay

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	volume fraction of the bone	Measured by Scanco microscanner	10 weeks
Secondary	thickness between trabecular	Measured by Scanco microscanner	10 weeks
Secondary	Thickness of trabecular	Measured by Scanco microscanner	10 weeks
Secondary	trabecular separation	Measured by Scanco microscanner	10 weeks
Secondary	trabecular number	Measured by Scanco microscanner	10 weeks
Secondary	structural model index	Measured by Scanco microscanner	10 weeks
Secondary	trabecular pattern factor	Measured by Scanco microscanner	10 weeks
Secondary	connectivity density	Measured by Scanco microscanner	10 weeks
Secondary	degree of anisotropy	Measured by Scanco microscanner	10 weeks