Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Not Applicable

Completed

• Conditions: Partially Edentulous Jaw
• Interventions: Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

• Registration Number: NCT01346696
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

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: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-08

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 implants	OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)	OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level Alteration	Evaluated from implant installation to 12 months 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading.; Positive value = bone gain, Negative values = bone loss.

Secondary Outcome Measures

Name	Time	Method
Marginal Bone Level Alteration After 36 Months	Evaluated from implant loading to 36 months 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading.; Positive value = bone gain, Negative values = bone loss.
Implant Stability	Evaluated 36 months after implant loading.	Implant stability evaluated clinically/manually (recorded as stable yes/no).
Implant Survival	Evaluated from implant installation to 36 months after implant loading.	Implant survival rate evaluated clinically and radiographically.
Condition of the Periimplant Mucosa (PPD).	Evaluated from implant loading to 36 months after implant loading.	Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD).; Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).; Negative value = increased pocket depth
Plaque	Evaluated 36 months after implant loading.	Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
Condition of the Periimplant Mucosa (BoP).	Evaluated from implant loading to 36 months after implant loading.	Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP).; Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.
Crown-to-implant Ratio	12 months after implant loading	Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs

Trial Locations

Locations (3)

Department of Periodontology, School of Stomatology, Peking University; 🇨🇳 Beijing, China

Second Dental and Periodontal Center, School of Stomatology, Peking University; 🇨🇳 Beijing, China

Department of Implantology, School of Stomatology, Peking University; 🇨🇳 Beijing, China