Dental Implant Failed, Peri-Implantitis, Peri-implant Mucositis
Conditions
Brief 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:
Interventions
DEVICEZirconia implant
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant success rate according to Buser's criteria | 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 |
Countries
Italy
Outcome results
None listed