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Short Implants - An Alternative to Bone Grafting?

Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01030523
Enrollment
101
Registered
2009-12-11
Start date
2009-10-31
Completion date
2022-03-22
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw, Edentulous, Partially

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.

Interventions

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

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

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

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

Sponsors

Dentsply Sirona Implants and Consumables
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant Survival Rate5 years after permanent restorationAny 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

MeasureTime frameDescription
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant LevelTime of permanent restoration and 5 years after permanent restorationMarginal 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.
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)5 years after permanent restorationBleeding 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 Measure by Average Change in Probing Pocket Depth (PPD) From Permanent RestorationTime of permanent restoration and 5 years after permanent restorationPPD 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.
Change in Overall Oral Health Impact Profile (OHIP-49)At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restorationOHIP-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.

Countries

Austria, Poland, Spain, Switzerland, United States

Participant flow

Recruitment details

The study was amended to include a 10-year follow-up cohort where all subjects enrolled into the initial 5-year study were invited. In total 77 out of the initial 101 subjects consented and were enrolled into the 10-years extension cohort.

Participants by arm

ArmCount
Short Implants
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
50
Long Implants in Combination With Bone Grafting
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
51
Total101

Withdrawals & dropouts

PeriodReasonFG000FG001
Follow-up Extension (10 Years)Adverse Event12
Follow-up Extension (10 Years)Lost to Follow-up54
Follow-up Extension (10 Years)Withdrawal by Subject13
Initial Study (5 Years)Death10
Initial Study (5 Years)Implant failure10
Initial Study (5 Years)Lost to Follow-up45

Baseline characteristics

CharacteristicShort ImplantsLong Implants in Combination With Bone GraftingTotal
Age, Continuous50.2 years
STANDARD_DEVIATION 12.88
50.5 years
STANDARD_DEVIATION 14.05
50.4 years
STANDARD_DEVIATION 13.4
Sex: Female, Male
Female
29 Participants23 Participants52 Participants
Sex: Female, Male
Male
21 Participants28 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 500 / 51
other
Total, other adverse events
23 / 5027 / 51
serious
Total, serious adverse events
6 / 507 / 51

Outcome results

Primary

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.

Time frame: 5 years after permanent restoration

Population: Outcome measure only applicable for the initial study (5 years) cohort.

ArmMeasureValue (COUNT_OF_UNITS)
Short ImplantsImplant Survival Rate66 Implants
Long Implants in Combination With Bone GraftingImplant Survival Rate70 Implants
Secondary

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.

Time frame: Time of permanent restoration and 5 years after permanent restoration

Population: Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. 10 subjects within the short implants group had missing or unreadable radiographs and could thus not be included in the analysis. The corresponding number for long implants group was 9 subjects with missing and unreadable radiographs.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsAverage Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level-0.12 MillimetreStandard Deviation 0.535
Long Implants in Combination With Bone GraftingAverage Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level-0.18 MillimetreStandard Deviation 0.959
Secondary

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.

Time frame: Time of permanent restoration and 10 years after permanent restoration

Population: Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. 7 subjects within the short implants group had missing or unreadable radiographs and could thus not be included in the analysis. The corresponding number for long implants group was 9 subjects with missing and unreadable radiographs.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsAverage Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level-0.12 MillimetreStandard Deviation 0.68
Long Implants in Combination With Bone GraftingAverage Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level-0.24 MillimetreStandard Deviation 0.82
Secondary

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.

Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration

Population: Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects with available OHIP-values from baseline and 10 years after permanent restoration were included in the analysis of overall OHIP-49.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsChange in Overall Oral Health Impact Profile (OHIP-49)-2.2 score on scaleStandard Deviation 19.1
Long Implants in Combination With Bone GraftingChange in Overall Oral Health Impact Profile (OHIP-49)-9.8 score on scaleStandard Deviation 16.3
Secondary

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.

Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration

Population: Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. All subjects with available OHIP-values from baseline and 5 years after permanent restoration were included in the analysis of overall OHIP-49.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsChange in Overall Oral Health Impact Profile (OHIP-49)-12 score on a scaleStandard Deviation 26.3
Long Implants in Combination With Bone GraftingChange in Overall Oral Health Impact Profile (OHIP-49)-16.9 score on a scaleStandard Deviation 23.9
Secondary

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.

Time frame: Time of permanent restoration and 5 years after permanent restoration

Population: Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. One subject in the short implants group did not have baseline PPD and was not included in the PPD analysis.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsCondition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration-0.26 MillimetreStandard Deviation 0.91
Long Implants in Combination With Bone GraftingCondition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration-0.43 MillimetreStandard Deviation 1.02
Secondary

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.

Time frame: Time of permanent restoration and 10 years after permanent restoration

Population: Follow-up Extension (10 years) cohort. At visit 15 (10-year follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects were included in the ITT population and were included in the analysis of PPD.

ArmMeasureValue (MEAN)Dispersion
Short ImplantsCondition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration-0.4 MillimetreStandard Deviation 1.2
Long Implants in Combination With Bone GraftingCondition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration-0.7 MillimetreStandard Deviation 1.5
Secondary

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.

Time frame: 5 years after permanent restoration

Population: Initial study (5 years) cohort. At visit 10 (5-year follow-up visit) 44 subjects remained in the short implants group, and 46 subjects remained in the long implants group. All subjects were included in the Intention-To-Treat population and were included in the analysis of BoP.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Short ImplantsCondition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)18 Participants
Long Implants in Combination With Bone GraftingCondition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)23 Participants
Secondary

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.

Time frame: 10 years after permanent restoration

Population: Follow-up Extension (10 years) cohort. At visit 15 (10-years follow-up visit) 29 subjects remained in the short implants group, and 32 subjects remained in the long implants group. All subjects were included in the ITT population and were included in the analysis of BoP.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Short ImplantsCondition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)16 Participants
Long Implants in Combination With Bone GraftingCondition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)23 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026