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

NCT03018457 | Completed

• 2 other identifiers: 1608111ANSM
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

Trabecular microarchitecture; alveolar bone; osseointegration; dental implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• volume fraction of the bone

  10 weeks

• thickness between trabecular

  10 weeks

• Thickness of trabecular

  10 weeks

• trabecular separation

  10 weeks

• trabecular number

  10 weeks

Study Arms (1)

patients who need a dental implants

Device: ISQ

Interventions

ISQ DEVICE

Measured by Osstell.

patients who need a dental implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need a dental implant

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Cabinet dentaire MOLIMARD

Le Puy-en-Velay, 43000, France

Location

Study Officials

• Thierry THOMAS, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: May 5, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)