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Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsseoSpeed™ length 6 mm
OsseoSpeed™ length 11 mm
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC School of Dentistry
  • The University of Iowa, College of Dentistry
  • School of Dental Science, University of Melbourne
  • Praktijk De Mondhoek
  • Dept. of Parodontology, Göteborg University
  • King's College London Dental Institute at Guy's King's and St Thomas' Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group-1, Implant length 6 mm

Group-2, Implant length 11 mm

Arm Description

Subjects treated with OsseoSpeed™ implant, length: 6 mm

Subjects treated with OsseoSpeed™ implant, length: 11 mm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Implant Survival
Overall implant survival, measured on implant level
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.
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.
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.

Full Information

First Posted
October 16, 2007
Last Updated
May 7, 2020
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00545818
Brief Title
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Official Title
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-1, Implant length 6 mm
Arm Type
Experimental
Arm Description
Subjects treated with OsseoSpeed™ implant, length: 6 mm
Arm Title
Group-2, Implant length 11 mm
Arm Type
Other
Arm Description
Subjects treated with OsseoSpeed™ implant, length: 11 mm
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™ length 6 mm
Intervention Description
OsseoSpeed™ dental implant, length: 6 mm
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™ length 11 mm
Intervention Description
OsseoSpeed™ dental implant, length: 11 mm
Primary Outcome Measure Information:
Title
Radiological Assessments of Marginal Bone Level Alteration
Description
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.
Time Frame
Evaluated from implant installation to 5 years follow-up after implant placement
Secondary Outcome Measure Information:
Title
Overall Implant Survival
Description
Overall implant survival, measured on implant level
Time Frame
Evaluated 5 years after implant placement
Title
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Description
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.
Time Frame
Measured at the 5-year follow-up visit after loading
Title
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Description
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.
Time Frame
Evaluated at implant loading and at the 5-year follow-up visit.
Title
Presence of Plaque
Description
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.
Time Frame
Evaluated at the 5-year follow-up visit after loading.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Karin Lundgren
Organizational Affiliation
Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
Official's Role
Study Director
Facility Information:
Facility Name
USC School of Dentistry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-0641
Country
United States
Facility Name
The University of Iowa, College of Dentistry
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1010
Country
United States
Facility Name
School of Dental Science, University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Facility Name
Praktijk De Mondhoek
City
Apeldoorn
ZIP/Postal Code
7315
Country
Netherlands
Facility Name
Dept. of Parodontology, Göteborg University
City
Göteborg
ZIP/Postal Code
SE 405 30
Country
Sweden
Facility Name
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22938573
Citation
Gulje 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.12001. Epub 2012 Sep 3.
Results Reference
result
PubMed Identifier
30003598
Citation
Zadeh HH, Gulje 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 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
Results Reference
result

Learn more about this trial

Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

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