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

Not Applicable

Completed

• Conditions: Partially Edentulous Jaw
• Interventions: Device: OsseoSpeed™ TX

• Registration Number: NCT01389258
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2014-08
• Study Completion: 2016-08
• Results First Submitted: 2019-02-11
• Results First Submitted QC: 2019-09-16
• Status Verified: 2019-10
• Results First Posted: 2019-10-08
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OsseoSpeed™ TX	OsseoSpeed™ TX	OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Primary Outcome Measures

Name	Time	Method
Implant Survival	Measured at the 3-year follow-up visit after implant loading.	Implant survival rate evaluated clinically and radiographically.

Secondary Outcome Measures

Name	Time	Method
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).	Measured at implant loading and at the 3-year follow-up visit after loading.	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.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).	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). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Presence of Plaque	Measured at the 3-year follow-up visit after implant loading.	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.
Implant Stability	Measured at the 3-year follow-up visit after implant loading.	Implant stability evaluated clinically/manually (recorded as stable yes/no).
Marginal Bone Level Alteration	Measured at the 3-year follow-up visit after implant loading.	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).
Gingival Zenith Score	Measured at implant loading and at the 3-year follow-up visit after loading.	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.

Trial Locations

Locations (3)

Tong Ji University, Oral Implants Department; 🇨🇳 Shanghai, China

Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University; 🇨🇳 Xi'an, China

School of Stomatology Wuhan University; 🇨🇳 Wuhan, China