Study on OsseoSpeed™ TX Short Implants in a Chinese Population

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.

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.

Study Overview

• Status: Completed
• Conditions: Partially Edentulous Jaw
• Intervention / Treatment: Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100081
    • Department of Periodontology, School of Stomatology, Peking University
  • Beijing, China
    • Department of Implantology, School of Stomatology, Peking University
  • Beijing, China
    • Second Dental and Periodontal Center, School of Stomatology, Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: OsseoSpeed™ TX implants; OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.	Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Implant Survival	Implant survival rate evaluated clinically and radiographically.	Evaluated from implant installation to 36 months after implant loading.
Implant Stability	Implant stability evaluated clinically/manually (recorded as stable yes/no).	Evaluated 36 months after implant loading.
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.
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.
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.
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

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Huan Xin Meng, Prof, Department of Periodontology, School of Stomatology, Beijing University

Publications and helpful links

General Publications

• 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. doi: 10.1111/clr.12587. Epub 2015 Apr 9.
• 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 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: CHN-0005