Study on OsseoSpeed™ TX Implants in a Chinese Population

Not Applicable

Completed

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

• Registration Number: NCT01346683
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible is a safe and predictable procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2019-02-11
• Results First Submitted QC: 2019-02-11
• Results First Posted: 2019-05-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

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

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	Evaluated 3 years after implant loading	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. 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
Implant Survival	From implant placement to the follow-up 36 months after loading.	Implant survival rate evaluated clinically and radiographically.
Implant Stability	Measured from loading of implants to the follow-up 36 months after loading.	Implant stability evaluated clinically/manually (recorded as stable yes/no)
Soft Tissue Status (PPD).	Measured from loading of implants to the follow-up 36 months after loading.	Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed.; A negative value = increased pocket depth.
Soft Tissue Status (BoP)	Measured from loading of implants to the follow-up 36 months after loading.	Soft tissue status measured by assessment of bleeding on probing (BoP).

Trial Locations

Locations (3)

Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University; 🇨🇳 Guangzhou, China

Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China

Department of Prosthodontics, School of Stomatology, Beijing University; 🇨🇳 Beijing, China