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

February 21, 2021 updated by: Irena Sailer, University of Geneva, Switzerland
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

partially edentulous patients

Description

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.
  • Patients treated or under treatment with intravenous amino- bisphosphonates.
  • Patients participating to other studies, if the present protocol could not be fully adhered to.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability Quotient (ISQ) changes
Time Frame: 3 years
the measurements will be performed with the instrument Penguin RFA
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant failure rate
Time Frame: 3 years
% of implant failure
3 years
patient satisfaction related to the implant treatment
Time Frame: 3 years
degree of satisfaction on factors such as function, comfort and esthetics through questionnaires
3 years
prosthetic failure rate
Time Frame: 3 years
% of prosthetic failure
3 years
implant complications rate
Time Frame: 3 years
% of implant complications
3 years
prosthetic complications rate
Time Frame: 3 years
% of prosthetic complications
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Geneva, Switzerland

Investigators

  • Principal Investigator: Irena Sailer, Prof. Dr., University of Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (ACTUAL)

February 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-00666

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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