Clinical trial NCT01346696: 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
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Jaw
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2011-05-03
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 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.


Eligibility criteria: Inclusion criteria:

1. Provision of informed consent
2. Female and male aged 20-75 years at enrolment
3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
4. History of edentulism in the study area of at least four months
5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
7. 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
8. 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. Earlier graft procedures in the study area
3. Uncontrolled pathologic processes in the oral cavity
4. Known or suspected current malignancy
5. History of radiation therapy in the head and neck region
6. History of chemotherapy within 5 years prior to surgery
7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
8. Uncontrolled diabetes mellitus
9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
10. Smoking more than 10 cigarettes/day
11. Present alcohol and/or drug abuse
12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
13. Previous enrolment in the present study
14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
15. Subjects that are unable to give informed consent

Primary outcomes:
measure: Marginal Bone Level Alteration
timeFrame: Evaluated from implant installation to 12 months after implant loading
Secondary outcomes:
measure: Marginal Bone Level Alteration After 36 Months
timeFrame: Evaluated from implant loading to 36 months after implant loading.
measure: Implant Survival
timeFrame: Evaluated from implant installation to 36 months after implant loading.
measure: Implant Stability
timeFrame: Evaluated 36 months after implant loading.
measure: Condition of the Periimplant Mucosa (PPD).
timeFrame: Evaluated from implant loading to 36 months after implant loading.
measure: Condition of the Periimplant Mucosa (BoP).
timeFrame: Evaluated from implant loading to 36 months after implant loading.
measure: Plaque
timeFrame: Evaluated 36 months after implant loading.
measure: Crown-to-implant Ratio
timeFrame: 12 months after implant loading
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Periodontology, School of Stomatology, Peking University
city: Beijing
country: China
facility: Department of Implantology, School of Stomatology, Peking University
city: Beijing
country: China
facility: Second Dental and Periodontal Center, School of Stomatology, Peking University
Study officials:
affiliation: Department of Periodontology, School of Stomatology, Beijing University
name: Huan Xin Meng, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.