Dental Implant FailedPhase 4NCT05838365
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants
A Phase 4 study testing Zirconia implant in people with Dental Implant Failed and Peri-implant Mucositis, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dental Implant Failed, Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- Zirconia implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 1 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Congenital (primary) or acquired (secondary) immunodeficiency
- Pregnant women
- Connective tissue disorders
- Local exclusion criteria:
- untreated stage III/IV periodontitis
- Autoimmune diseases
- oral parafunctions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Paolo Hospital
Milan
Eugenio Romeo, Full Professor, +39 0250319039, eugenio.romeo@unimi.it
About this study
Official title: Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
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:
- Being tested
- Zirconia implant
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia implantDevice
(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading zirconia implant | Experimental | Loading of zirconia dental implant within 7 days after implant placement Receives: Device: Zirconia implant |
| Delayed loading zirconia implant | Active comparator | Loading of zirconia dental implants after at least 2 months of healing Receives: Device: Zirconia implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Palazzolo, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838365
- Sponsor's protocol ID
- 74/22
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Primary and secondary endpoints; indicators of central tendency; evidence summary; tables; figures.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05838365
- Acronym / sponsor ID
- 74/22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading zirconia implant | Experimental | Device: Zirconia implantLoading of zirconia dental implant within 7 days after implant placement |
| Delayed loading zirconia implant | Active comparator | Device: Zirconia implantLoading of zirconia dental implants after at least 2 months of healing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sistemically healthy patients
- partial edentulism
- premolar position
- molar position
- Bone width and height at least 6 and 10mm, respectively.
Key exclusion criteria (13 listed)
- Heavy smokers (>10 cigarettes a day)
- Serious kidney or liver diseases
- Uncontrolled diabetes
- Bisphosphonates intake
- History of radiotherapy of the head and neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia implant(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement) | Device | Delayed loading zirconia implant, Immediate loading zirconia implant |
Primary outcome
Implant success rate according to Buser's criteria
Time frame: 5 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided. Primary and secondary endpoints; indicators of central tendency; evidence summary; tables; figures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zirconia implant in people with Dental Implant Failed and Peri-implant Mucositis, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate according to Buser's criteria (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.