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.

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.

Study Overview

• Status: Completed
• Conditions: Implant Clinical Survival; Dental Implant Bone Loss
• Intervention / Treatment: Device: SPI implant

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jinan, China
    • West China Hospital of Stomatology
  • Shanghai, China
    • The Affiliated Stomatology Hospital of Tongji University
  • Yantai, China
    • Stomatology Hospital of Shandong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPI dental implant; Subjects implanted with SPI implant	Device: SPI implant; SPI implant - the original spiral implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative Survival Rate	24 months

Collaborators and Investigators

• Sponsor: Alpha - Bio Tec Ltd.
• Investigators: Principal Investigator: Yi Man, Dr, West China Hospital of Stomatology, Chengdu, Sichuan China

Publications and helpful links

Helpful Links

• Sponsor's site

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: SPI-001