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

Implant Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769934
• Other study ID #: 2018-00666
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: February 2021
• Source: University of Geneva, Switzerland
• Contact: Irena Sailer, Prof. Dr.
• Phone: +41 22 3794050
• Email: irena.sailer[@]unige.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Implant Complication

Intervention

Device:
• Penguin RFA
to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	implant failure rate	% of implant failure	3 years
Other	patient satisfaction related to the implant treatment	degree of satisfaction on factors such as function, comfort and esthetics through questionnaires	3 years
Other	prosthetic failure rate	% of prosthetic failure	3 years
Other	implant complications rate	% of implant complications	3 years
Other	prosthetic complications rate	% of prosthetic complications	3 years
Primary	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	Implant Stability Quotient (ISQ) changes	the measurements will be performed with the instrument Penguin RFA	3 years