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Short Implants - An Alternative to Bone Grafting?

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of informed consent
  • Aged 20-75 years at enrolment
  • History of edentulism in the study area of at least four months
  • In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region)
  • Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator
  • Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s
  • Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 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 bone 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, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes/day
  • Bruxism
  • 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
  • Simultaneous participation in another clinical study

Sites / Locations

  • Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine
  • Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
  • Aesthetic Dent
  • Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
  • Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short Implants

Long Implants in combination with bone grafting

Arm Description

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)

ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

Outcomes

Primary Outcome Measures

Implant Survival Rate
Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant.

Secondary Outcome Measures

Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Marginal bone level will be 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 millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Marginal bone level will be 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 millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level.
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort.
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Change in Overall Oral Health Impact Profile (OHIP-49)
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.
Change in Overall Oral Health Impact Profile (OHIP-49)
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.

Full Information

First Posted
December 10, 2009
Last Updated
March 9, 2023
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT01030523
Brief Title
Short Implants - An Alternative to Bone Grafting?
Official Title
Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.
Detailed Description
This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.

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
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Implants
Arm Type
Experimental
Arm Description
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Arm Title
Long Implants in combination with bone grafting
Arm Type
Active Comparator
Arm Description
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Intervention Type
Device
Intervention Name(s)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Intervention Description
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Intervention Type
Device
Intervention Name(s)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Intervention Description
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Primary Outcome Measure Information:
Title
Implant Survival Rate
Description
Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant.
Time Frame
5 years after permanent restoration
Secondary Outcome Measure Information:
Title
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Description
Marginal bone level will be 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 millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Time Frame
Time of permanent restoration and 5 years after permanent restoration
Title
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Description
Marginal bone level will be 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 millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Time Frame
Time of permanent restoration and 10 years after permanent restoration
Title
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Description
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level.
Time Frame
5 years after permanent restoration
Title
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Description
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort.
Time Frame
10 years after permanent restoration
Title
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Description
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Time Frame
Time of permanent restoration and 5 years after permanent restoration
Title
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Description
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Time Frame
Time of permanent restoration and 10 years after permanent restoration
Title
Change in Overall Oral Health Impact Profile (OHIP-49)
Description
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.
Time Frame
At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration
Title
Change in Overall Oral Health Impact Profile (OHIP-49)
Description
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.
Time Frame
At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent Aged 20-75 years at enrolment History of edentulism in the study area of at least four months In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region) Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 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 bone 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, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration Smoking more than 10 cigarettes/day Bruxism 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 Simultaneous participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Hämmerle, Prof. Dr.
Organizational Affiliation
Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Aesthetic Dent
City
Szczecin
ZIP/Postal Code
P-71-403
Country
Poland
Facility Name
Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
ES-15782
Country
Spain
Facility Name
Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
City
Zürich
ZIP/Postal Code
CH-8032
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25418606
Citation
Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.
Results Reference
result
PubMed Identifier
26425812
Citation
Schincaglia GP, Thoma DS, Haas R, Tutak M, Garcia A, Taylor TD, Hammerle CH. Randomized controlled multicenter study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 2: clinical and radiographic outcomes at 1 year of loading. J Clin Periodontol. 2015 Nov;42(11):1042-51. doi: 10.1111/jcpe.12465. Epub 2015 Nov 27.
Results Reference
result
PubMed Identifier
28081288
Citation
Pohl V, Thoma DS, Sporniak-Tutak K, Garcia-Garcia A, Taylor TD, Haas R, Hammerle CH. Short dental implants (6 mm) versus long dental implants (11-15 mm) in combination with sinus floor elevation procedures: 3-year results from a multicentre, randomized, controlled clinical trial. J Clin Periodontol. 2017 Apr;44(4):438-445. doi: 10.1111/jcpe.12694. Epub 2017 Mar 6.
Results Reference
result
PubMed Identifier
30341961
Citation
Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hammerle CHF. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 5-Year data. J Clin Periodontol. 2018 Dec;45(12):1465-1474. doi: 10.1111/jcpe.13025. Epub 2018 Nov 25.
Results Reference
result

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Short Implants - An Alternative to Bone Grafting?

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