Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

April 26, 2023 updated by: Antonino Palazzolo, University of Milan

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial

The main aim of the present study is to investigate implant success rate after 5 years of function of immediate (Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement) loading of two-pieces zirconia implant, placed in pristine bone without bone regeneration. Implant success rate will be defined according to Buser's criteria. Secondary endpoints: Marginal bone level (MBL) evaluation by means of standardized radiographs; Clinical evaluation of biological (e.g. Plaque Index, PI; Probing Pocket Depth, PPD, Bleeding on Probing, BOP; suppuration upon probing/palpation) and prosthetic/technical complications; Clinical evaluation of soft tissue width, keratinized tissue, marginal and interproximal soft tissue recession; Patient reported outcome measures (PROMs) by questionnaire administration:

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

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
      • Milano, Italy
        • Recruiting
        • San Paolo Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sistemically healthy patients
  • partial edentulism
  • premolar position
  • molar position
  • Bone width and height at least 6 and 10mm, respectively.
  • Keratinized tissue, at least 1 mm at implant site
  • Full understanding of the proposed surgical treatments and the protocol schedule
  • Full comprehension and availability to sign the informed consent form

Exclusion Criteria:

  • Heavy smokers (>10 cigarettes a day)
  • Serious kidney or liver diseases
  • Uncontrolled diabetes
  • Bisphosphonates intake
  • History of radiotherapy of the head and neck
  • Current antiblastic chemotherapy
  • Congenital (primary) or acquired (secondary) immunodeficiency
  • Pregnant women
  • Connective tissue disorders

Local exclusion criteria:

  • untreated stage III/IV periodontitis
  • Autoimmune diseases
  • oral parafunctions

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate loading zirconia implant
Loading of zirconia dental implant within 7 days after implant placement
Device: Zirconia implant
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Active Comparator: Delayed loading zirconia implant
Loading of zirconia dental implants after at least 2 months of healing
Device: Zirconia implant
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant success rate according to Buser's criteria
Time Frame: 5 years
presence of subjective complaints related to the area of treatment; recurrent infections in the peri-implant region accompanied by suppuration; mobility of the implant fixture
5 years

Collaborators and Investigators

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

Sponsor

University of Milan

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)

December 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2029

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Primary and secondary endpoints; indicators of central tendency; evidence summary; tables; figures.

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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