Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Partially Edentulous Jaw Clinical Trial

Official title:

An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346696
• Other study ID #: CHN-0005
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: March 2016

Study information

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

Clinical Trial Summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

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. Female and male aged 20-75 years at enrolment

3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)

4. History of edentulism in the study area of at least four months

5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)

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

7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm

8. 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. Uncontrolled pathologic processes in the oral cavity

4. Known or suspected current malignancy

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

6. History of chemotherapy within 5 years prior to surgery

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

8. Uncontrolled diabetes mellitus

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

10. Smoking more than 10 cigarettes/day

11. Present alcohol and/or drug abuse

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

13. Previous enrolment in the present study

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

15. Subjects that are unable to give informed consent

Related Conditions & MeSH terms

• Jaw, Edentulous
• Partially Edentulous Jaw

Intervention

Device:
• OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

Locations

Country	Name	City	State
China	Department of Implantology, School of Stomatology, Peking University	Beijing
China	Department of Periodontology, School of Stomatology, Peking University	Beijing
China	Second Dental and Periodontal Center, School of Stomatology, Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

China, 

References & Publications (2)

Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 — View Citation

Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed(™) TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. — 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading.; Positive value = bone gain, Negative values = bone loss.	Evaluated from implant installation to 12 months after implant loading
Secondary	Marginal Bone Level Alteration After 36 Months	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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading.; Positive value = bone gain, Negative values = bone loss.	Evaluated from implant loading to 36 months after implant loading.
Secondary	Implant Survival	Implant survival rate evaluated clinically and radiographically.	Evaluated from implant installation to 36 months after implant loading.
Secondary	Implant Stability	Implant stability evaluated clinically/manually (recorded as stable yes/no).	Evaluated 36 months after implant loading.
Secondary	Condition of the Periimplant Mucosa (PPD).	Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD).; Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).; Negative value = increased pocket depth	Evaluated from implant loading to 36 months after implant loading.
Secondary	Condition of the Periimplant Mucosa (BoP).	Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP).; Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.	Evaluated from implant loading to 36 months after implant loading.
Secondary	Plaque	Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.	Evaluated 36 months after implant loading.
Secondary	Crown-to-implant Ratio	Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs	12 months after implant loading