Trial Outcomes & Findings for Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation (NCT NCT02404649)
NCT ID: NCT02404649
Last Updated: 2020-07-22
Results Overview
Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
8 months
Results posted on
2020-07-22
Participant Flow
Recruitment of patients were fulfilled in a timely manner. Patients were were down from the existing patient pool at the Harvard School of Dental medicine.
Three participants were excluded from the trial due to early dental implant failures. These three events were caused by local infections and thus subsequent readings were not taken.
Participant milestones
| Measure |
Bone Augmention
Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation
|
Sinus Elevation Only
Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Bone Augmention
Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation
|
Sinus Elevation Only
Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation
Baseline characteristics by cohort
| Measure |
Bone Augmention
n=16 Participants
Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation
|
Sinus Elevation Only
n=14 Participants
Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 monthsImplant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.
Outcome measures
| Measure |
Bone Augmention
n=16 Participants
Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation
|
Sinus Elevation Only
n=14 Participants
Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only
|
|---|---|---|
|
Resonance Frequency Values of Dental Implants
|
83.04 units on a scale
Standard Deviation 3.94
|
80.59 units on a scale
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: 2 yearsEvaluating crestal bone levels were performed by measuring (millimeters) vertical bone height gain in the maxillary 2 years postoperatively from CBCT images between control and test group.
Outcome measures
| Measure |
Bone Augmention
n=13 Participants
Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation
|
Sinus Elevation Only
n=11 Participants
Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only
|
|---|---|---|
|
Crestal Bone Levels
|
13.05 millimeters
Standard Deviation 1.73
|
11.68 millimeters
Standard Deviation 1.4
|
Adverse Events
Bone Augmention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sinus Elevation Only
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
Restriction type: LTE60