Clinical Performance Evaluation of Two Different Dental Implants


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.

Full Title of Study: “Clinical Performance Evaluation of a Hyaluronic Acid-coated Hybrid Dental Implant Compared to a Non-Coated Standard Rough Dental Implant: A Pragmatic Multi-center Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2020


  • Device: dental implant-supported restoration
    • During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant

Arms, Groups and Cohorts

  • Experimental: HA-coated hybrid implant
    • Patient allocated to this group will receive an iMAX® Hyaluronic Acid-coated hybrid dental implant for their dental implant-supported restoration.
  • Active Comparator: Moderately rough implant
    • Patient allocated in this group will receive an iMAX® non-coated moderately rough dental implant with a machined neck their dental implant-supported restoration.

Clinical Trial Outcome Measures

Primary Measures

  • Survival Rate
    • Time Frame: 12 months after implant placement
    • Cumulative implant survival rate

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Elite Odontoiatrica
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luca Ferrantino, Researcher – Elite Odontoiatrica


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