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

Partially Edentulous Jaw Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473355
• Other study ID #: CHN-0003
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: October 2019
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria:

1. Provision of informed consent

2. Aged 20-75 years at enrolment

3. History of edentulism in the study area of at least two months

4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns

5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant

6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator

2. Uncontrolled pathologic processes in the oral cavity

3. Known or suspected current malignancy

4. History of radiation therapy in the head and neck region

5. History of chemotherapy within 5 years prior to surgery

6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator

7. Uncontrolled diabetes mellitus

8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration

9. Smoking more than 10 cigarettes per day

10. Present alcohol and/or drug abuse

11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)

12. Previous enrollment in the present study

13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Partially Edentulous Jaw

Intervention

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

Locations

Country	Name	City	State
China	School of Stomatology, JiLin University, Hospital of Stomatology	Changchun
China	Sichuan University	Chengdu
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Survived Implants	Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function	Measured at the 3 year follow-up after implant loading.
Secondary	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).	Measured at the 3 year follow-up after implant loading.
Secondary	Number of Stable Implants	Implant stability evaluated clinically/manually (recorded as stable yes/no).	Measured at the 3 year follow-up after implant loading.
Secondary	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.	Measured at the 3 year follow-up after implant loading.
Secondary	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.	Measured at the 3 year follow-up after implant loading.
Secondary	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.	Measured at the 3 year follow-up after implant loading.