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

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. 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 mandible 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
  • Changchun, China
    • School of Stomatology, JiLin University, Hospital of Stomatology
  • Chengdu, China, 610041
    • Sichuan University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, College of Medicine, Zhejiang 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 enrolment
3. History of edentulism in the study area of at least two months
4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
6. 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) in lengths of 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
Number of Survived Implants	Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function	Measured at the 3 year follow-up after implant loading.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Level Alteration	Marginal bone level determined from radiographs and expressed as the distance 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).	Measured at the 3 year follow-up after implant loading.
Number of Stable Implants	Implant stability evaluated clinically/manually (recorded as stable yes/no).	Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.	Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of 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 the 3 year follow-up after implant loading.
Presence of Plaque	Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.	Measured at the 3 year follow-up after implant loading.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Ping Gong, Prof, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 7, 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-0003