Back to resultsImmediate Versus Delayed Loading of Single Posterior Zirconia Implants
Primary Purpose
Dental Implant Failed, Peri-implant Mucositis, Peri-Implantitis
Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Zirconia implant
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant Failed
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
Sites / Locations
- San Paolo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate loading zirconia implant
Delayed loading zirconia implant
Arm Description
Loading of zirconia dental implant within 7 days after implant placement
Loading of zirconia dental implants after at least 2 months of healing
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05838365
Brief Title
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
Official Title
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Peri-implant Mucositis, Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate loading zirconia implant
Arm Type
Experimental
Arm Description
Loading of zirconia dental implant within 7 days after implant placement
Arm Title
Delayed loading zirconia implant
Arm Type
Active Comparator
Arm Description
Loading of zirconia dental implants after at least 2 months of healing
Intervention Type
Device
Intervention Name(s)
Zirconia implant
Intervention Description
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
Primary Outcome Measure Information:
Title
Implant success rate according to Buser's criteria
Description
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
San Paolo Hospital
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Romeo, Full Professor
Phone
+39 0250319039
Email
eugenio.romeo@unimi.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Primary and secondary endpoints; indicators of central tendency; evidence summary; tables; figures.
Learn more about this trial
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
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