Implant Clinical SurvivalPhase 4SPINCT02367261
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant
A Phase 4 study testing SPI implant in people with Implant Clinical Survival and Dental Implant Bone Loss, run by Alpha - Bio Tec Ltd. at 4 sites in China.
Trial summary
The current prospective clinical study's aim is to determine ABT's SPI implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of SPI implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Clinical Survival, Dental Implant Bone Loss
- What is being tested?
- SPI implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2014to Jun 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 18 years who need implantation of 1-4 implants.
- Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
- Patients who had provided written informed consent to participate in the study prior to any study procedure.
- Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.
Who cannot join
- Immediate loaded implants.
- Patient requiring bone augmentation
- Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
- Treatment with anticonvulsants drugs.
- Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
- Patients with history of alcohol, narcotics or drug abuse.
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- Patients under steroid therapy.
- Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.
- Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
- Metabolic bone disorders and/or bone augmentation.
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
- Degenerative diseases.
- Osteoradionecrosis.
- Renal failure.
- Organ transplant recipients.
- HIV positive.
- Malignant diseases.
- Diseases that compromise the immune system.
- Unbalanced diabetes mellitus. (HbA1c above 6.5)
- Psychotic diseases.
- Hypersensitivity to one of the components of the implant in general and titanium in particular.
- Women who are pregnant or lactating.
- Lack of patient cooperation.
- Uncontrolled endocrine diseases.
- Any systemic condition that is unbalanced and therefore precludes surgical procedures.
- Parafunctional habits.- e.g Bruxism.
- Temporomandibular joint disease.
- Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
- Flapless procedures.
- -
Trial locations and contacts
4 sites in 1 country.
China4 sites
West China Hospital of Stomatology
Chengdu, Sichuan
West China Hospital of Stomatology
Jinan
The Affiliated Stomatology Hospital of Tongji University
Shanghai
Stomatology Hospital of Shandong University
Yantai
About this study
Official title: An Open, Prospective, Multi-center Study to Evaluate Bone Loss, the Survival Rate of SPI Implant System and Implant Stability Over a 24 Months, in Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol.
The current prospective clinical study's aim is to determine ABT's SPI implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of SPI implants.
- Being tested
- SPI implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI implantDevice
SPI implant - the original spiral implant
| Study group | Role | What they receive |
|---|---|---|
| SPI dental implant | Experimental | Subjects implanted with SPI implant Receives: Device: SPI implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Survival Rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Clinical SurvivalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha - Bio Tec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Man, Dr, Principal investigator, West China Hospital of Stomatology, Chengdu, Sichuan China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367261
- Sponsor's protocol ID
- SPI-001
- Acronym
- SPI
- Status last verified
- Jun 2017
- First submitted
- 12 Feb 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multi-center Study to Evaluate Bone Loss, the Survival Rate of SPI Implant System and Implant Stability Over a 24 Months, in Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol.
- ClinicalTrials.gov ID
- NCT02367261
- Acronym / sponsor ID
- SPI / SPI-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Alpha - Bio Tec Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Feb 2015 (estimated)
- 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 current prospective clinical study's aim is to determine ABT's SPI implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of SPI implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI dental implant | Experimental | Device: SPI implantSubjects implanted with SPI implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over the age of 18 years who need implantation of 1-4 implants.
- Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
- Patients who had provided written informed consent to participate in the study prior to any study procedure.
- Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.
Key exclusion criteria (30 listed)
- Immediate loaded implants.
- Patient requiring bone augmentation
- Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
- Treatment with anticonvulsants drugs.
- Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
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 |
|---|---|---|
| SPI implantSPI implant - the original spiral implant | Device | SPI dental implant |
Primary outcome
Cumulative Survival Rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Sponsor's siteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Yi Man, Dr principal investigator
West China Hospital of Stomatology, Chengdu, Sichuan China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SPI implant in people with Implant Clinical Survival and Dental Implant Bone Loss, run by Alpha - Bio Tec Ltd. at 4 sites in China.
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 4 inclusion and 30 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: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Survival Rate (time frame: 24 months). 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 28 Jun 2017.