Trial Outcomes & Findings for A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols (NCT NCT00607022)
NCT ID: NCT00607022
Last Updated: 2018-07-27
Results Overview
The objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-07-27
Participant Flow
Participant milestones
| Measure |
Immediate Load
immediate load of dental implant based on the bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
6 Week Load
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
12 Week Load
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
15
|
19
|
|
Overall Study
COMPLETED
|
6
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Immediate Load
immediate load of dental implant based on the bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
6 Week Load
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
12 Week Load
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
Baseline characteristics by cohort
| Measure |
Immediate Load
n=7 Participants
immediate load of dental implant based on the bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
6 Week Load
n=15 Participants
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
12 Week Load
n=19 Participants
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 7 • n=99 Participants
|
35 years
STANDARD_DEVIATION 8 • n=107 Participants
|
34 years
STANDARD_DEVIATION 5 • n=206 Participants
|
34 years
STANDARD_DEVIATION 7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
15 participants
n=107 Participants
|
19 participants
n=206 Participants
|
41 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.
Outcome measures
| Measure |
Immediate Load
n=7 Participants
immediate load of dental implant based on the bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
6 Week Load
n=15 Participants
delayed load (6 weeks post surgery) of dental implants based on bone quality determined by the insertion torque value
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
12 Week Load
n=19 Participants
traditional loading of dental implants (12 weeks post surgery) based on bone quality determined by the insertin torque value.
dental implant: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach.
|
|---|---|---|---|
|
Implant Stability Scale (ISQ) Score Change After 16 Weeks
16 weeks
|
83 units on a scale
Standard Deviation 3.6
|
83 units on a scale
Standard Deviation 3
|
83 units on a scale
Standard Deviation 2
|
|
Implant Stability Scale (ISQ) Score Change After 16 Weeks
0
|
73 units on a scale
Standard Deviation 6.67
|
71 units on a scale
Standard Deviation 4.47
|
69 units on a scale
Standard Deviation 3
|
|
Implant Stability Scale (ISQ) Score Change After 16 Weeks
6 weeks
|
78 units on a scale
Standard Deviation 2.57
|
77 units on a scale
Standard Deviation 3.1
|
77 units on a scale
Standard Deviation 3.0
|
|
Implant Stability Scale (ISQ) Score Change After 16 Weeks
12 weeks
|
81 units on a scale
Standard Deviation 3.3
|
81 units on a scale
Standard Deviation 3.4
|
81 units on a scale
Standard Deviation 3.5
|
Adverse Events
6 Week Load
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Week Load
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Load
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place