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NCT Number: NCT05838365

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

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:

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Key information

Conditions

Dental Implant Failed Mouth Diseases Peri-Implantitis Peri-implant Mucositis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconia implant

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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