NCT05838365 Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
| NCT ID | NCT05838365 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Milan |
| Condition | Dental Implant Failed |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2024-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 220 participants in total. It began in 2022-12-01 with a primary completion date of 2024-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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:
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
Frequently Asked Questions
Who can join the NCT05838365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dental Implant Failed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05838365 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05838365 currently recruiting?
Yes, NCT05838365 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Milan to inquire about joining.
Where is the NCT05838365 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05838365 clinical trial?
NCT05838365 is sponsored by University of Milan. The trial plans to enroll 220 participants.