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Clinical Trials/NCT04769934
NCT04769934
Unknown
Not Applicable

Impact of Implant Insertion Torque on Peri-implant Bone Level.

University of Geneva, Switzerland1 site in 1 country93 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant Complication
Sponsor
University of Geneva, Switzerland
Enrollment
93
Locations
1
Primary Endpoint
radiographic marginal bone level changes around the implant platform
Last Updated
5 years ago

Overview

Brief Summary

Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.

Detailed Description

The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform. The secondary outcomes would be: * To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA * To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates * The patient satisfaction related to the implant treatment

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
August 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Geneva, Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Irena Sailer

Prof. Dr. Irena Sailer, Head of the Division

University of Geneva, Switzerland

Eligibility Criteria

Inclusion Criteria

  • All partially edentulous patients requiring simple Implant placement,
  • being at least 18-year-old and able to sign an informed consent,
  • The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).

Exclusion Criteria

  • Heavy smokers (more than 10 cigarettes/day).
  • Immunosuppressed or immunocompromised patients
  • Uncontrolled diabetes
  • Active periodontal disease
  • Patients with a full mouth marginal bleeding score higher than 20%
  • Addiction to alcohol or drugs
  • Psychiatric problems
  • Severe caries, periapical lesions, acute infection (abscess)
  • Immediate post-extractive implants (at least 2 months after extraction have to elapse)
  • Patients unable to commit to 3-year follow-up.

Outcomes

Primary Outcomes

radiographic marginal bone level changes around the implant platform

Time Frame: 3 years

the changes (in mm) of the marginal bone level around the implant platform

Secondary Outcomes

  • Implant Stability Quotient (ISQ) changes(3 years)

Study Sites (1)

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