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

Primary Purpose

Partially Edentulous Jaw

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

OsseoSpeed™ TX

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
Aged 20-75 years at enrolment
History of edentulism in the study area of at least two months
Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
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
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, as deemed by the investigator
Uncontrolled diabetes mellitus
Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
Smoking more than 10 cigarettes per 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 enrollment in the present study
Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Sites / Locations

School of Stomatology, JiLin University, Hospital of Stomatology
Sichuan University
The First Affiliated Hospital, College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OsseoSpeed™ TX

Arm Description

OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm

Outcomes

Primary Outcome Measures

Number of Survived Implants

Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

Secondary Outcome Measures

Marginal Bone Level Alteration

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).

Number of Stable Implants

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

Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD

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.

Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP

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

Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.

Full Information

NCT ID

NCT01473355

First Posted

November 15, 2011

Last Updated

October 7, 2019

Sponsor

Dentsply Sirona Implants and Consumables

1. Study Identification

Unique Protocol Identification Number

NCT01473355

Brief Title

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

Official Title

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior 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

October 2011 (Actual)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

October 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 3mm diameter implant 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 3 mm implant is a safe and predictable procedure.

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

Arm Type

Experimental

Arm Description

OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm

Intervention Type

Device

Intervention Name(s)

OsseoSpeed™ TX

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Survived Implants

Description

Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function

Time Frame