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

• Conditions: Implant Complication

• Registration Number: NCT04769934
• Lead Sponsor: University of Geneva, Switzerland

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

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
radiographic marginal bone level changes around the implant platform	3 years	the changes (in mm) of the marginal bone level around the implant platform

Secondary Outcome Measures

Name	Time	Method
Implant Stability Quotient (ISQ) changes	3 years	the measurements will be performed with the instrument Penguin RFA

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland