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Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

Sponsor
University of Milan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05838365
Collaborator
(none)
220
Enrollment
1
Location
2
Arms
78
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Condition or Disease Intervention/Treatment Phase
  • Device: Zirconia implant
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2029

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Implant success rate according to Buser's criteria [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Paolo Hospital Milano Italy

Sponsors and Collaborators

  • University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonino Palazzolo, Dr. Principal Investigator, University of Milan
ClinicalTrials.gov Identifier:
NCT05838365
Other Study ID Numbers:
  • 74/22
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Mucositis
Peri-Implantitis

Study Results

No Results Posted as of May 1, 2023