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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545818
Other study ID # YA-SHO-0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2007
Est. completion date May 2016

Study information

Verified date May 2020
Source Dentsply Sirona Implants
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Provision of informed consent

- Aged 20-70 years at enrolment

- History of edentulism in the study area of at least four months

- Neighboring tooth/teeth to the planned bridge must have natural root(s)

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

- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm

- 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

- Earlier graft procedures in the study area

- 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

- Uncontrolled diabetes mellitus

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

- Smoking more than 10 cigarettes/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 enrolment in the present study.

- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OsseoSpeed™ length 6 mm
OsseoSpeed™ dental implant, length: 6 mm
OsseoSpeed™ length 11 mm
OsseoSpeed™ dental implant, length: 11 mm

Locations

Country Name City State
Australia School of Dental Science, University of Melbourne Melbourne Victoria
Netherlands Praktijk De Mondhoek Apeldoorn
Sweden Dept. of Parodontology, Göteborg University Göteborg
United Kingdom King's College London Dental Institute at Guy's King's and St Thomas' Hospitals London
United States The University of Iowa, College of Dentistry Iowa City Iowa
United States USC School of Dentistry Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

United States,  Australia,  Netherlands,  Sweden,  United Kingdom, 

References & Publications (2)

Guljé F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12 — View Citation

Zadeh HH, Guljé F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Au — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological Assessments of Marginal Bone Level Alteration Marginal Bone Level determined from radiographs and expressed as the difference 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 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).
Positive value = bone gain, Negative value = bone loss.
Evaluated from implant installation to 5 years follow-up after implant placement
Secondary Overall Implant Survival Overall implant survival, measured on implant level Evaluated 5 years after implant placement
Secondary Evaluation of the Periimplant Mucosa Condition - By Assessment BoP Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP. Measured at the 5-year follow-up visit after loading
Secondary Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD).
Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).
Negative value = increased pocket depth.
Evaluated at implant loading and at the 5-year follow-up visit.
Secondary Presence of Plaque Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.
A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.
Evaluated at the 5-year follow-up visit after loading.
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