Trial Outcomes & Findings for Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible (NCT NCT03509402)
NCT ID: NCT03509402
Last Updated: 2025-01-13
Results Overview
Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
5 years from baseline (prosthetic loading)
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
Short Implants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible
Baseline characteristics by cohort
| Measure |
Short Implants
n=15 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=15 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
61 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
63 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Smoking habit
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years from baseline (prosthetic loading)Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.
Outcome measures
| Measure |
Short Implants
n=13 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=14 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Marginal Bone Level (MBL) Change
|
0.30 mm
Standard Deviation 0.31
|
0.40 mm
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 5 years from baseline (prosthetic loading)A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated).
Outcome measures
| Measure |
Short Implants
n=13 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=14 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Implant Survival Rate
|
65 Implants
|
70 Implants
|
SECONDARY outcome
Timeframe: 5 years from baseline (prosthetic loading)A surviving prosthesis is defined as still in place at the time of the follow-up.
Outcome measures
| Measure |
Short Implants
n=13 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=14 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Prosthesis Survival
|
13 Prostheses
|
14 Prostheses
|
SECONDARY outcome
Timeframe: 5 years from baseline (prosthetic loading)Peri-implant mucositis and peri-implantitis
Outcome measures
| Measure |
Short Implants
n=13 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=14 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Biological Complications
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 years from baseline (prosthetic loading)Technical complications are categorized in minor and major complications. The formers require only chair-side repair and include screw loosening and veneer material fracture. The latters require additional laboratory procedures and/or replacement components and include prosthesis or framework fracture, screw fracture, implant fracture, and extended wear requiring veneer renewal.
Outcome measures
| Measure |
Short Implants
n=13 Participants
A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
|
Long Implants
n=14 Participants
A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
|
|---|---|---|
|
Technical Complications
|
7 Participants
|
5 Participants
|
Adverse Events
Short Implants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Implants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Marco Annunziata
University of Campania "Luigi Vanvitelli"
Phone: 0815665515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place