Clinical Performance Evaluation of Two Different Dental Implants (HAHy-vs-C)

Elite Odontoiatrica

Status: Active, not recruiting

Conditions: Edentulism

Treatments: Device: dental implant-supported restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT03845335

Protocol 01

Details and patient eligibility

About

In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Signed informed consent to participate to the present investigation
• Psychological appropriateness and good compliance to dentist instructions
• Patient who have been selected for implant therapy by an experienced surgeon.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

HA-coated hybrid implant

Experimental group

Description:

Patient allocated to this group will receive an iMAX® Hyaluronic Acid-coated hybrid dental implant for their dental implant-supported restoration.

Treatment:

Device: dental implant-supported restoration

Moderately rough implant

Active Comparator group

Description:

Patient allocated in this group will receive an iMAX® non-coated moderately rough dental implant with a machined neck their dental implant-supported restoration.

Treatment:

Device: dental implant-supported restoration