Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Study Overview

• Status: Completed
• Conditions: Partially Edentulous Jaw
• Intervention / Treatment: Device: OsseoSpeed™ TX

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

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Tong Ji University, Oral Implants Department
  • Wuhan, China, 430079
    • School of Stomatology Wuhan University
  • Xi'an, China, 710032
    • Dept. of Oral Implants, School of Stomatology, Fourth Military Medical 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. Aged 20-75 years at enrollment
3. History of edentulism in the study area of at least two months
4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
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. Uncontrolled pathologic processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
9. Smoking more than 10 cigarettes per day
10. Present alcohol and/or drug abuse
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrollment in the present study
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

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; OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm	Device: OsseoSpeed™ TX; OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival	Implant survival rate evaluated clinically and radiographically.	Measured at the 3-year follow-up visit after implant loading.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Stability	Implant stability evaluated clinically/manually (recorded as stable yes/no).	Measured at the 3-year follow-up visit after implant loading.
Marginal Bone Level Alteration	Marginal Bone Level (mm) determined from radiographs and expressed as a 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 obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).	Measured at the 3-year follow-up visit after implant loading.
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).	Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.	Measured at implant loading and at the 3-year follow-up visit after loading.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.	Measured at implant loading and at the 3-year follow-up visit after loading.
Presence of Plaque	Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.	Measured at the 3-year follow-up visit after implant loading.
Gingival Zenith Score	Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm. Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.	Measured at implant loading and at the 3-year follow-up visit after loading.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Li Dehua, Prof, Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 8, 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-0006