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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02367261

Acronym

SPI

Enrollment

Registered

2015-02-20

Start date

2014-11-30

Completion date

2017-06-30

Last updated

2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Bone Loss, Implant Clinical Survival

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.

Interventions

DEVICESPI implant

SPI implant - the original spiral implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame
Cumulative Survival Rate	24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026