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

Completed

• Conditions: Dental Implant
• Interventions: Device: ISQ

• Registration Number: NCT03018457
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-05-05
• Status Verified: 2018-02
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who need a dental implants	ISQ	-

Primary Outcome Measures

Name	Time	Method
Implant Stability Quotient (ISQ)	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

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

Trial Locations

Locations (1)

Cabinet dentaire MOLIMARD; 🇫🇷 Le Puy En Velay, France