Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Milan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Sistemically healthy patients
partial edentulism
premolar position
molar position
Disqualifiers
Heavy smokers (>10 cigarettes a day)
Serious kidney or liver diseases
Uncontrolled diabetes
Bisphosphonates intake
Trial design
Design model
Parallel
Treatments tested in this trial
Zirconia implant
Device(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Immediate loading zirconia implantExperimental treatment 1 intervention
Group B: Delayed loading zirconia implantActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov