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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.

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.

Condition or disease Intervention/treatment Phase
Implant Clinical Survival Dental Implant Bone Loss Device: SPI implant Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: SPI dental implant
Subjects implanted with SPI implant
Device: SPI implant
SPI implant - the original spiral implant




Primary Outcome Measures :
  1. Cumulative Survival Rate [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367261


Locations
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China, Sichuan
West China Hospital of Stomatology
Chengdu, Sichuan, China
China
West China Hospital of Stomatology
Jinan, China
The Affiliated Stomatology Hospital of Tongji University
Shanghai, China
Stomatology Hospital of Shandong University
Yantai, China
Sponsors and Collaborators
Alpha - Bio Tec Ltd.
Investigators
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Principal Investigator: Yi Man, Dr West China Hospital of Stomatology, Chengdu, Sichuan China

Additional Information:
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Responsible Party: Alpha - Bio Tec Ltd.
ClinicalTrials.gov Identifier: NCT02367261     History of Changes
Other Study ID Numbers: SPI-001
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017