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

Not Applicable

Completed

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

• Registration Number: NCT01389245
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior maxilla 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: 2015-07
• Study Completion: 2017-09
• Status Verified: 2020-04
• Results First Submitted: 2020-04-22
• Results First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Results First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OsseoSpeed™ TX	OsseoSpeed™ TX	OsseoSpeed™ TX implants of lengths 8-17 mm

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level Alteration	Measured at implant loading and at the 3-year follow-up after implant loading.	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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	Measured at the 3-year follow-up after implant loading.	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.
Number of Survived Implants	Measured at the 3-year follow-up after implant loading.	Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
Presence of Plaque	Measured at the 3-year follow-up after implant loading.	Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3-year follow-up visit after implant loading.
Number of Stable Implants	Measured at the 3-year follow-up after implant loading.	Implant stability evaluated clinically/manually (recorded as stable yes/no).

Trial Locations

Locations (3)

Guanghua School of Stomatology, Sun Yat-Sen University; 🇨🇳 Guangzhou, China

Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University; 🇨🇳 Nanjing, China

Capital Medical University School of Stomatology, Centre of Oral Implantation; 🇨🇳 Beijing, China