A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant
SPI
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.
1 other identifier
interventional
88
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
Typical duration for phase_4
4 active sites
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 28, 2017
June 1, 2017
2.6 years
February 12, 2015
June 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Survival Rate
24 months
Study Arms (1)
SPI dental implant
EXPERIMENTALSubjects implanted with SPI implant
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
West China Hospital of Stomatology
Chengdu, Sichuan, China
West China Hospital of Stomatology
Jinan, China
The Affiliated Stomatology Hospital of Tongji University
Shanghai, China
Stomatology Hospital of Shandong University
Yantai, China
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Man, Dr
West China Hospital of Stomatology, Chengdu, Sichuan China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 20, 2015
Study Start
November 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 28, 2017
Record last verified: 2017-06