Impact of Implant Insertion Torque on Peri-implant Bone Level.
1 other identifier
observational
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedFebruary 25, 2021
February 1, 2021
3 years
February 17, 2021
February 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
radiographic marginal bone level changes around the implant platform
the changes (in mm) of the marginal bone level around the implant platform
3 years
Secondary Outcomes (1)
Implant Stability Quotient (ISQ) changes
3 years
Other Outcomes (5)
implant failure rate
3 years
patient satisfaction related to the implant treatment
3 years
prosthetic failure rate
3 years
- +2 more other outcomes
Interventions
to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
Eligibility Criteria
partially edentulous patients
You may qualify if:
- 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).
You may not qualify if:
- 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.
- Patients treated or under treatment with intravenous amino- bisphosphonates.
- Patients participating to other studies, if the present protocol could not be fully adhered to.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Geneva
Geneva, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Irena Sailer, Prof. Dr.
University of Geneva
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Irena Sailer, Head of the Division
Study Record Dates
First Submitted
February 17, 2021
First Posted
February 25, 2021
Study Start
August 1, 2018
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02