Trial Outcomes & Findings for Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period (NCT NCT02701387)
NCT ID: NCT02701387
Last Updated: 2016-12-29
Results Overview
Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)
COMPLETED
NA
7 participants
Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)
2016-12-29
Participant Flow
Participant milestones
| Measure |
All Participants
Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
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|---|---|
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Overall Study
STARTED
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7
|
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Overall Study
COMPLETED
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7
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Implant Thread Design on Implant Stability Quotient (ISQ) in Early Healing Period
Baseline characteristics by cohort
| Measure |
All Participants
n=7 Participants
Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
|
|---|---|
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Age, Continuous
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60.4 years
n=93 Participants
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Gender
Female
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0 Participants
n=93 Participants
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Gender
Male
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7 Participants
n=93 Participants
|
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Region of Enrollment
United States
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7 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)Population: Seven participants, each missing at least two posterior teeth in the same arch, were enrolled, resulting in 10 matched pairs for analysis. Outcome was assessed per implant, not per individual participant;
Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)
Outcome measures
| Measure |
AnyRidge Implant
n=10 implants
Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.
Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth).
|
EZ Plus Implant
n=10 implants
Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.
Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market.
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|---|---|---|
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Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T0
|
79.6 units on a scale
Standard Deviation 1.61
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80.1 units on a scale
Standard Deviation 1.37
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T1
|
79.7 units on a scale
Standard Deviation 1.58
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79.7 units on a scale
Standard Deviation 1.31
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T2
|
80.0 units on a scale
Standard Deviation 1.26
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79.2 units on a scale
Standard Deviation 1.29
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T3
|
80.1 units on a scale
Standard Deviation 0.81
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78.3 units on a scale
Standard Deviation 1.41
|
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Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T4
|
80.3 units on a scale
Standard Deviation 0.75
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77.5 units on a scale
Standard Deviation 2.03
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T5
|
80.3 units on a scale
Standard Deviation 0.75
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77.4 units on a scale
Standard Deviation 2.41
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T6
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80.2 units on a scale
Standard Deviation 0.85
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77.3 units on a scale
Standard Deviation 2.70
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Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T7
|
80.4 units on a scale
Standard Deviation 0.77
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77.3 units on a scale
Standard Deviation 2.74
|
|
Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone
T8
|
80.6 units on a scale
Standard Deviation 0.71
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77.1 units on a scale
Standard Deviation 2.73
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Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Perry R. Klokkevold, DDS, MS, FACD
UCLA School of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place