Clinical trial NCT02367261: A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implant Clinical Survival
Dental Implant Bone Loss
Lead sponsor: Alpha - Bio Tec Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

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Primary outcomes:
measure: Cumulative Survival Rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology
state: Sichuan
city: Jinan
country: China
facility: West China Hospital of Stomatology
city: Shanghai
country: China
facility: The Affiliated Stomatology Hospital of Tongji University
city: Yantai
country: China
facility: Stomatology Hospital of Shandong University
Study officials:
affiliation: West China Hospital of Stomatology, Chengdu, Sichuan China
name: Yi Man, Dr
role: PRINCIPAL_INVESTIGATOR
References: