Actively Recruiting
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
Led by University of Milan · Updated on 2023-05-01
220
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the success rate of zirconia dental implants in patients with partial tooth loss in premolar or molar positions. This study compares immediate loading of implants within 7 days after placement to delayed loading after 8 weeks. The main goal is to assess implant success over 5 years based on Buser's criteria. Secondary measures include bone level changes, biological and technical complications, soft tissue health, and patient-reported outcomes. Participants receive a two-piece zirconia implant placed in natural bone without bone regeneration. They are randomly assigned to either immediate loading within 7 days or delayed loading after at least 2 months of healing. Both groups are monitored for biological and prosthetic complications, soft tissue changes, and implant performance during the study period. During the trial, participants undergo standardized radiographs to track bone levels, clinical exams for gum health and complications, and complete questionnaires to report their experience. Researchers evaluate plaque, pocket depth, bleeding, and tissue changes around the implant. The study lasts at least 5 years to measure long-term implant success and safety under medical supervision.
CONDITIONS
Brief Title
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sistemically healthy patients
- Partial edentulism
- Premolar position
- Molar position
- Bone width at least 6 mm and height at least 10 mm
- Keratinized tissue at least 1 mm at implant site
- Full understanding of proposed surgical treatments and protocol schedule
- Full comprehension and availability to sign the informed consent form
You will not qualify if you...
- Heavy smokers (more than 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 or acquired immunodeficiency
- Pregnant women
- Connective tissue disorders
- Untreated stage III/IV periodontitis
- Autoimmune diseases
- Oral parafunctions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implant placement
Participants receive a zirconia dental implant placement.
1 visit (in-person)
Duration - Up to 8 weeks depending on loading time
Participants receive loading of the zirconia implant either immediately within 7 days or delayed at least 8 weeks after implant placement.
1 to 2 visits depending on loading schedule
Duration - 5 years
Participants are monitored for implant success and healing over 5 years.
Periodic visits for implant assessment
Trial Site Locations
Total: 1 location
1
San Paolo Hospital
Milan, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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