Study on OsseoSpeed™ TX Implants in a Chinese Population

Partially Edentulous Jaw Clinical Trial

Official title:

An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Mandible. A 3-years Follow-up Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346683
• Other study ID #: CHN-0002
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2019
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible is a safe and predictable procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria:

1. Provision of informed consent

2. Aged 20-75 years at enrolment

3. History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.

4. Neighboring tooth to the planned bridge must have natural root.

5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.

6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.

7. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator

2. Earlier graft procedures in the study area

3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.

4. Uncontrolled pathologic processes in the oral cavity

5. Known or suspected current malignancy

6. History of radiation therapy in the head and neck region

7. History of chemotherapy within 5 years prior to surgery

8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration

9. Uncontrolled diabetes mellitus

10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration

11. Smoking more than 10 cigarettes/day

12. Present alcohol and/or drug abuse

13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)

14. Previous enrolment in the present study.

15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.

16. Subjects that are unable to give informed consent

Related Conditions & MeSH terms

• Jaw, Edentulous
• Partially Edentulous Jaw

Intervention

Device:
• OsseoSpeed TX
OsseoSpeed TX implants of lengths 8-17 mm

Locations

Country	Name	City	State
China	Department of Prosthodontics, School of Stomatology, Beijing University	Beijing
China	Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University	Guangzhou
China	Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhou J, Huang Q, Wang X, Peng D, Li Y, Zhang L, Liu J, Zhang S, Zhao K, Jiang X, Zhou Y. Early loading of splinted implants in the posterior mandible: a prospective multicentre case series. J Clin Periodontol. 2016 Mar;43(3):298-304. doi: 10.1111/jcpe.125 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Level Alteration	Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).	Evaluated 3 years after implant loading
Secondary	Implant Survival	Implant survival rate evaluated clinically and radiographically.	From implant placement to the follow-up 36 months after loading.
Secondary	Implant Stability	Implant stability evaluated clinically/manually (recorded as stable yes/no)	Measured from loading of implants to the follow-up 36 months after loading.
Secondary	Soft Tissue Status (PPD).	Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed.; A negative value = increased pocket depth.	Measured from loading of implants to the follow-up 36 months after loading.
Secondary	Soft Tissue Status (BoP)	Soft tissue status measured by assessment of bleeding on probing (BoP).	Measured from loading of implants to the follow-up 36 months after loading.