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

U

University of Geneva, Switzerland

Status

Unknown

Conditions

Implant Complication

Treatments

Device: Penguin RFA

Study type

Observational

Funder types

Other

Identifiers

NCT04769934
2018-00666

Details and patient eligibility

About

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.

Full 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

Enrollment

93 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Irena Sailer, Prof. Dr.

Data sourced from clinicaltrials.gov

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