Osseointegration Failure of Dental Implant Due to InfectionNCT03336723
Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial
A study testing Dental Implant in people with Osseointegration Failure of Dental Implant Due to Infection and Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading, run by Implantology Institute.
Trial summary
2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osseointegration Failure of Dental Implant Due to Infection, Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
- What is being tested?
- Dental Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.
Who cannot join
- 1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial
2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values<0.05 were considered statistically significant
- Conditions
- Osseointegration Failure of Dental Implant Due to Infection, Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
- Being tested
- Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantDevice
Place a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Two piece zirconia dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3. Receives: Device: Dental Implant |
| Control Group | Active comparator | Two piece titanium dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3. Receives: Device: Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseointegration
measure if the healing process of bone was successful
Measured: from T0 to T2 - 2 month
Marginal bone loss
measure bone level from T0 baseline to T3
Measured: 4 month after T0
IL1b concentration
Measure IL fluid at T0 and T2 for IL1b characterization
Measured: 4 month
IL6 concentration
Measure IL fluid at T0 and T2 for IL1b characterization
Measured: 4 month
Microbiologic samples
Measure crevicular fluid at T0 and T2 for bacteria characterization
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osseointegration Failure of Dental Implant Due to InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336723
- Sponsor's protocol ID
- II10
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial
- ClinicalTrials.gov ID
- NCT03336723
- Acronym / sponsor ID
- II10
- Conditions
- Osseointegration Failure of Dental Implant Due to Infection, Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 8 Nov 2017 (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.
2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values<0.05 were considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Dental ImplantTwo piece zirconia dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3. |
| Control Group | Active comparator | Device: Dental ImplantTwo piece titanium dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.
Key exclusion criteria (2 listed)
- 1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity
- -
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 |
|---|---|---|
| Dental ImplantPlace a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken | Device | Control Group, Experimental Group |
Primary outcome
Osseointegration
Time frame: from T0 to T2 - 2 month
measure if the healing process of bone was successful
Marginal bone loss
Time frame: 4 month after T0
measure bone level from T0 baseline to T3
IL1b concentration
Time frame: 4 month
Measure IL fluid at T0 and T2 for IL1b characterization
IL6 concentration
Time frame: 4 month
Measure IL fluid at T0 and T2 for IL1b characterization
Microbiologic samples
Time frame: 4 month
Measure crevicular fluid at T0 and T2 for bacteria characterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant in people with Osseointegration Failure of Dental Implant Due to Infection and Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading, run by Implantology Institute.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena cervino, DMD (00351919774343, elecer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseointegration (time frame: from T0 to T2 - 2 month). The study lists 5 primary outcomes in all. 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 8 Nov 2017.