Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zirconia implant.
- Who it may be relevant to
- Registry conditions: Dental Implant Failed, Peri-implant Mucositis, Peri-Implantitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
Overview
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:
Interventions
- Device Zirconia implant
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Primary outcome measures
- Implant success rate according to Buser's criteria [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- San Paolo Hospital — Milan
Identifiers
NCT: NCT05838365 · 74/22