Trial Outcomes & Findings for Comparing Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments (NCT NCT03572244)
NCT ID: NCT03572244
Last Updated: 2022-01-03
Results Overview
Determine if there is a difference in peri-implant crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for peri-implant crevicular fluid that is next to Laser-Lok microgrooved (LL) and machined (M) healing abutments after a healing period of 8 weeks after implant placement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
8 weeks after implant placement
Results posted on
2022-01-03
Participant Flow
Of the 23 enrolled participants, 12 met the inclusion criteria, were randomized to treatment, and completed the study.
Participant milestones
| Measure |
Laser-Lok
A Laser-Lok microgrooved implant will be placed.
Laser-Lok: A microgrooved abutment will be placed
|
Machine
A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Laser-Lok
n=6 Participants
A Laser-Lok microgrooved implant will be placed.
Laser-Lok: A microgrooved abutment will be placed
|
Machine
n=6 Participants
A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=6 Participants
|
61 years
n=6 Participants
|
62 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after implant placementDetermine if there is a difference in peri-implant crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for peri-implant crevicular fluid that is next to Laser-Lok microgrooved (LL) and machined (M) healing abutments after a healing period of 8 weeks after implant placement.
Outcome measures
| Measure |
Laser-Lok
n=6 Participants
A Laser-Lok microgrooved implant will be placed.
Laser-Lok: A microgrooved abutment will be placed
|
Machine
n=6 Participants
A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed
|
|---|---|---|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL8
|
6.54 log pg/ml
Standard Deviation 0.60
|
5.52 log pg/ml
Standard Deviation 1.06
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP1
|
4.48 log pg/ml
Standard Deviation 0.64
|
3.89 log pg/ml
Standard Deviation 0.72
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIP10
|
1.29 log pg/ml
Standard Deviation 0.79
|
1.32 log pg/ml
Standard Deviation 1.09
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP8b
|
11.37 log pg/ml
Standard Deviation 0.37
|
10.61 log pg/ml
Standard Deviation 1.11
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logTNFa
|
2.25 log pg/ml
Standard Deviation 1.18
|
2.15 log pg/ml
Standard Deviation 1.00
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL6
|
1.80 log pg/ml
Standard Deviation 0.31
|
1.61 log pg/ml
Standard Deviation 0.36
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL_1B
|
5.19 log pg/ml
Standard Deviation 0.61
|
4.92 log pg/ml
Standard Deviation 1.08
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP13
|
5.73 log pg/ml
Standard Deviation 0.94
|
5.78 log pg/ml
Standard Deviation 1.08
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logENA78
|
4.05 log pg/ml
Standard Deviation 0.53
|
3.27 log pg/ml
Standard Deviation 0.65
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMIG
|
6.95 log pg/ml
Standard Deviation 0.12
|
6.63 log pg/ml
Standard Deviation 0.51
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logOsteopontin
|
6.44 log pg/ml
Standard Deviation 1.19
|
6.50 log pg/ml
Standard Deviation 0.96
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logITAC1
|
2.53 log pg/ml
Standard Deviation 0.36
|
2.56 log pg/ml
Standard Deviation 0.84
|
|
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logOsteoprotegerin
|
2.94 log pg/ml
Standard Deviation 0.95
|
3.38 log pg/ml
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: 8 weeks after implant placementDetermine if there is a difference in gingival crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for gingival crevicular fluid that is next to Laser-Lok microgrooved abutments (LL) and machined (M) habutments after a healing period of 8 weeks after implant placement.
Outcome measures
| Measure |
Laser-Lok
n=6 Participants
A Laser-Lok microgrooved implant will be placed.
Laser-Lok: A microgrooved abutment will be placed
|
Machine
n=6 Participants
A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed
|
|---|---|---|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logTNFa
|
2.52 log pg/ml
Standard Deviation 0.50
|
2.13 log pg/ml
Standard Deviation 1.15
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL6
|
1.86 log pg/ml
Standard Deviation 0.09
|
2.39 log pg/ml
Standard Deviation 1.06
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL8
|
6.30 log pg/ml
Standard Deviation 0.84
|
6.29 log pg/ml
Standard Deviation 1.31
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP1
|
4.12 log pg/ml
Standard Deviation 0.35
|
4.47 log pg/ml
Standard Deviation 0.62
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIP10
|
1.13 log pg/ml
Standard Deviation 0.84
|
2.05 log pg/ml
Standard Deviation 2.14
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP8b
|
11.10 log pg/ml
Standard Deviation 0.50
|
11.17 log pg/ml
Standard Deviation 0.76
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logIL_1B
|
4.70 log pg/ml
Standard Deviation 0.82
|
5.06 log pg/ml
Standard Deviation 0.80
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMMP13
|
5.63 log pg/ml
Standard Deviation 0.36
|
5.18 log pg/ml
Standard Deviation 1.87
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logENA78
|
3.94 log pg/ml
Standard Deviation 0.79
|
3.75 log pg/ml
Standard Deviation 0.68
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logMIG
|
6.88 log pg/ml
Standard Deviation 0.18
|
6.95 log pg/ml
Standard Deviation 0.32
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logOsteopontin
|
6.82 log pg/ml
Standard Deviation 0.49
|
6.56 log pg/ml
Standard Deviation 1.21
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logITAC1
|
2.48 log pg/ml
Standard Deviation 0.20
|
2.18 log pg/ml
Standard Deviation 1.01
|
|
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
logOsteoprotegerin
|
2.84 log pg/ml
Standard Deviation 1.56
|
3.69 log pg/ml
Standard Deviation 0.82
|
Adverse Events
Laser-Lok
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Machine
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