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

NCT ID: NCT04769934

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-08-01

Brief Summary

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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

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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

Conditions

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Implant Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Penguin RFA

to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Irena Sailer

Prof. Dr. Irena Sailer, Head of the Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irena Sailer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

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University of Geneva

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Irena Sailer, Prof. Dr.

Role: CONTACT

+41 22 3794050

Facility Contacts

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Irena Sailer, Prof. Dr.

Role: primary

+41 22 3794050

Other Identifiers

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2018-00666

Identifier Type: -

Identifier Source: org_study_id

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