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Clinical Trials in Italy / NCT05838365
Recruiting Phase 4

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

NCT05838365 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milan
Phase
Phase 4
Started
2022-12-01
Last updated
2023-05-01

Condition(s) studied

Dental Implant FailedPeri-implant MucositisPeri-Implantitis

Investigational drug(s) / intervention(s)

Zirconia implant

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

Study 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:

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 exclusion criteria: * untreated stage III/IV periodontitis * Autoimmune diseases * oral parafunctions

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
San Paolo Hospital Milan Italy Recruiting

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Other trials for the same condition

Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment Recruiting
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05838365 on ClinicalTrials.gov ↗ ← All trials in Italy