Clinical trial NCT01389258: Study on OsseoSpeed™ TX Narrow Implants in the Upper 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 Maxilla. A 3-years Follow-up Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Jaw
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.


Eligibility criteria: Inclusion criteria:

1. Provision of informed consent
2. Aged 20-75 years at enrollment
3. History of edentulism in the study area of at least two months
4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
7. 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

Primary outcomes:
measure: Implant Survival
timeFrame: Measured at the 3-year follow-up visit after implant loading.
Secondary outcomes:
measure: Implant Stability
timeFrame: Measured at the 3-year follow-up visit after implant loading.
measure: Marginal Bone Level Alteration
timeFrame: Measured at the 3-year follow-up visit after implant loading.
measure: Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
timeFrame: Measured at implant loading and at the 3-year follow-up visit after loading.
measure: Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
timeFrame: Measured at implant loading and at the 3-year follow-up visit after loading.
measure: Presence of Plaque
timeFrame: Measured at the 3-year follow-up visit after implant loading.
measure: Gingival Zenith Score
timeFrame: Measured at implant loading and at the 3-year follow-up visit after loading.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tong Ji University, Oral Implants Department
city: Wuhan
country: China
facility: School of Stomatology Wuhan University
city: Xi'an
country: China
facility: Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Study officials:
affiliation: Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
name: Li Dehua, Prof
role: PRINCIPAL_INVESTIGATOR
References: