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

June 11, 2022 updated by: Luca Ferrantino, Elite Odontoiatrica

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Magenta, MI, Italy
        • Elite Odontoiatrica Magenta
      • Milano, MI, Italy
        • Elite Odontoiatrica Milano
      • Opera, MI, Italy
        • Elite Odontoiatrica Opera
    • VA
      • Caronno Pertusella, VA, Italy
        • Elite Odontoiatrica Caronno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: 12 months after implant placement
Cumulative implant survival rate
12 months after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elite Odontoiatrica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 16, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 11, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Protocol 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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