RecruitingPhase 4NCT05838365

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

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


Sponsor

University of Milan

Enrollment

220 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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:


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria12

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

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Interventions

DEVICEZirconia implant

(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)


Locations(1)

San Paolo Hospital

Milan, Italy

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NCT05838365


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