Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

Study Overview
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Brief Summary
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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:

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

Conditions
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Dental Implant Failed, Peri-implant Mucositis, Peri-Implantitis

Intervention / Treatment
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* Device: Zirconia implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant success rate according to Buser's criteria | 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 |