Back to results

Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Primary Purpose

Partially Edentulous Jaw

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Partially Edentulous Jaw

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Provision of informed consent
Female and male aged 20-75 years at enrolment
In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
History of edentulism in the study area of at least four months
Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

Unlikely to be able to comply with study procedures, as judged by the investigator
Earlier graft procedures in the study area
Uncontrolled pathologic processes in the oral cavity
Known or suspected current malignancy
History of radiation therapy in the head and neck region
History of chemotherapy within 5 years prior to surgery
Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
Uncontrolled diabetes mellitus
Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
Smoking more than 10 cigarettes/day
Present alcohol and/or drug abuse
Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
Previous enrolment in the present study
Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Subjects that are unable to give informed consent

Sites / Locations

Department of Periodontology, School of Stomatology, Peking University
Department of Implantology, School of Stomatology, Peking University
Second Dental and Periodontal Center, School of Stomatology, Peking University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OsseoSpeed™ TX implants

Arm Description

OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Outcomes

Primary Outcome Measures

Marginal Bone Level Alteration

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

Marginal Bone Level Alteration After 36 Months

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 Survival

Implant survival rate evaluated clinically and radiographically.

Implant Stability

Implant stability evaluated clinically/manually (recorded as stable yes/no).

Condition of the Periimplant Mucosa (PPD).

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

Condition of the Periimplant Mucosa (BoP).

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.

Plaque

Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.

Crown-to-implant Ratio

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

Full Information

NCT ID

NCT01346696

First Posted

May 2, 2011

Last Updated

October 1, 2019

Sponsor

Dentsply Sirona Implants and Consumables

1. Study Identification

Unique Protocol Identification Number

NCT01346696

Brief Title

Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Official Title

An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 2011 (Actual)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dentsply Sirona Implants and Consumables

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partially Edentulous Jaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OsseoSpeed™ TX implants

Arm Type

Experimental

Arm Description

OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Intervention Type

Device

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Marginal Bone Level Alteration

Description

Time Frame

Evaluated from implant installation to 12 months after implant loading

Secondary Outcome Measure Information:

Title

Marginal Bone Level Alteration After 36 Months

Description

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.

Time Frame

Evaluated from implant loading to 36 months after implant loading.

Title

Implant Survival

Description

Implant survival rate evaluated clinically and radiographically.

Time Frame

Evaluated from implant installation to 36 months after implant loading.

Title

Implant Stability

Description

Implant stability evaluated clinically/manually (recorded as stable yes/no).

Time Frame

Evaluated 36 months after implant loading.

Title

Condition of the Periimplant Mucosa (PPD).

Description

Time Frame

Evaluated from implant loading to 36 months after implant loading.

Title

Condition of the Periimplant Mucosa (BoP).

Description

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.

Time Frame

Evaluated from implant loading to 36 months after implant loading.

Title

Plaque

Description

Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.

Time Frame

Evaluated 36 months after implant loading.

Title

Crown-to-implant Ratio

Description

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

Time Frame

12 months after implant loading

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Provision of informed consent Female and male aged 20-75 years at enrolment In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region) History of edentulism in the study area of at least four months Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s) Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm Deemed by the investigator as likely to present an initially stable implant situation Exclusion criteria: Unlikely to be able to comply with study procedures, as judged by the investigator Earlier graft procedures in the study area Uncontrolled pathologic processes in the oral cavity Known or suspected current malignancy History of radiation therapy in the head and neck region History of chemotherapy within 5 years prior to surgery Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration Uncontrolled diabetes mellitus Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration Smoking more than 10 cigarettes/day Present alcohol and/or drug abuse Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) Previous enrolment in the present study Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months Subjects that are unable to give informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huan Xin Meng, Prof

Organizational Affiliation

Department of Periodontology, School of Stomatology, Beijing University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Periodontology, School of Stomatology, Peking University

City

Beijing

ZIP/Postal Code

100081

Country

China

Facility Name

Department of Implantology, School of Stomatology, Peking University

City

Beijing

Country

China

Facility Name

Second Dental and Periodontal Center, School of Stomatology, Peking University

City

Beijing

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25855871

Citation

Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed() TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. doi: 10.1111/clr.12587. Epub 2015 Apr 9.

Results Reference

result

PubMed Identifier

29218810

Citation

Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 Dec 8.

Results Reference

result

Learn more about this trial

Study on OsseoSpeed™ TX Short Implants in a Chinese Population

We'll reach out to this number within 24 hrs