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A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant (SPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367261
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Alpha - Bio Tec Ltd.

Tracking Information
First Submitted Date  ICMJE February 12, 2015
First Posted Date  ICMJE February 20, 2015
Last Update Posted Date June 28, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
Cumulative Survival Rate [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Implant Clinical Survival
  • Dental Implant Bone Loss
Intervention  ICMJE Device: SPI implant
SPI implant - the original spiral implant
Study Arms  ICMJE Experimental: SPI dental implant
Subjects implanted with SPI implant
Intervention: Device: SPI implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2017)
88
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2015)
90
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women over the age of 18 years who need implantation of 1-4 implants.
  2. Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
  3. Patients who had provided written informed consent to participate in the study prior to any study procedure.
  4. Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.

Exclusion Criteria:

  1. Immediate loaded implants.
  2. Patient requiring bone augmentation
  3. Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
  4. Treatment with anticonvulsants drugs.
  5. Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
  6. Patients with history of alcohol, narcotics or drug abuse.
  7. Patients under steroid therapy.
  8. 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.

  9. Metabolic bone disorders and/or bone augmentation.
  10. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
  11. Degenerative diseases.
  12. Osteoradionecrosis.
  13. Renal failure.
  14. Organ transplant recipients.
  15. HIV positive.
  16. Malignant diseases.
  17. Diseases that compromise the immune system.
  18. Unbalanced diabetes mellitus. (HbA1c above 6.5)
  19. Psychotic diseases.
  20. Hypersensitivity to one of the components of the implant in general and titanium in particular.
  21. Women who are pregnant or lactating.
  22. Lack of patient cooperation.
  23. Uncontrolled endocrine diseases.
  24. Any systemic condition that is unbalanced and therefore precludes surgical procedures.
  25. Parafunctional habits.- e.g Bruxism.
  26. Temporomandibular joint disease.
  27. 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.
  28. Flapless procedures.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02367261
Other Study ID Numbers  ICMJE SPI-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alpha - Bio Tec Ltd.
Study Sponsor  ICMJE Alpha - Bio Tec Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yi Man, Dr West China Hospital of Stomatology, Chengdu, Sichuan China
PRS Account Alpha - Bio Tec Ltd.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP