Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
1 other identifier
interventional
220
1 country
1
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
ExpectedMay 1, 2023
April 1, 2023
1.5 years
March 5, 2023
April 26, 2023
Conditions
Outcome Measures
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
5 years
Study Arms (2)
Immediate loading zirconia implant
EXPERIMENTALLoading of zirconia dental implant within 7 days after implant placement
Delayed loading zirconia implant
ACTIVE COMPARATORLoading of zirconia dental implants after at least 2 months of healing
Interventions
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- untreated stage III/IV periodontitis
- Autoimmune diseases
- oral parafunctions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Paolo Hospital
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Principal Investigator
Study Record Dates
First Submitted
March 5, 2023
First Posted
May 1, 2023
Study Start
December 1, 2022
Primary Completion
June 1, 2024
Study Completion (Estimated)
June 1, 2029
Last Updated
May 1, 2023
Record last verified: 2023-04