Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
- Conditions
- Partially Edentulous Jaw
- Interventions
- Device: OsseoSpeed™ TX
- Registration Number
- NCT01473355
- Lead Sponsor
- Dentsply Sirona Implants and Consumables
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OsseoSpeed™ TX OsseoSpeed™ TX OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
- Primary Outcome Measures
Name Time Method Number of Survived Implants Measured at the 3 year follow-up after implant loading. Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function
- Secondary Outcome Measures
Name Time Method Number of Stable Implants Measured at the 3 year follow-up after implant loading. Implant stability evaluated clinically/manually (recorded as stable yes/no).
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD Measured at the 3 year follow-up after implant loading. 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 Measured at the 3 year follow-up after implant loading. 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 Measured at the 3 year follow-up after implant loading. 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.
Marginal Bone Level Alteration Measured at the 3 year follow-up after implant loading. 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).
Trial Locations
- Locations (3)
Sichuan University
🇨🇳Chengdu, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, China
School of Stomatology, JiLin University, Hospital of Stomatology
🇨🇳Changchun, China