Trial Outcomes & Findings for Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis (NCT NCT03400475)
NCT ID: NCT03400475
Last Updated: 2018-12-19
Results Overview
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
COMPLETED
PHASE2
46 participants
Baseline- 24hrs
2018-12-19
Participant Flow
Participant milestones
| Measure |
Test Group
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
Baseline characteristics by cohort
| Measure |
Test Group
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.45 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline- 24hrsMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 1 B at Base to 24 Hours
|
-1.075 Micrograms per deciliter (ug/dl)
Standard Deviation 15.587
|
1.013 Micrograms per deciliter (ug/dl)
Standard Deviation 5.273
|
PRIMARY outcome
Timeframe: Baseline - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 1 B at Base to 1 Week
|
2.5016 Micrograms per deciliter (ug/dl)
Standard Deviation 15.4701
|
-1.095 Micrograms per deciliter (ug/dl)
Standard Deviation 8.6050
|
PRIMARY outcome
Timeframe: 24 hours - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 1 B 24 Hours - 1 Week
|
3.577 Micrograms per deciliter (ug/dl)
Standard Deviation 14.137
|
-2.108 Micrograms per deciliter (ug/dl)
Standard Deviation 10.569
|
PRIMARY outcome
Timeframe: Baseline - 24 hoursMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 6 at Base to 24 Hours
|
0.118 Micrograms per deciliter (ug/dl)
Standard Deviation 0.954
|
0.201 Micrograms per deciliter (ug/dl)
Standard Deviation 0.880
|
PRIMARY outcome
Timeframe: Baseline - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 6 Baseline to 1 Week
|
0.304 Micrograms per deciliter (ug/dl)
Standard Deviation 1.3744
|
0.275 Micrograms per deciliter (ug/dl)
Standard Deviation 1.296
|
PRIMARY outcome
Timeframe: 24 hours - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 6 24 Hours - 1 Week
|
0.185 Micrograms per deciliter (ug/dl)
Standard Deviation 2.039
|
0.073 Micrograms per deciliter (ug/dl)
Standard Deviation 1.522
|
PRIMARY outcome
Timeframe: Baseline - 24 hoursMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 8 at Base to 24 Hours
|
0.00 Micrograms per deciliter (ug/dl)
Standard Deviation 331.021
|
64.696 Micrograms per deciliter (ug/dl)
Standard Deviation 197.902
|
PRIMARY outcome
Timeframe: Baseline - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 8 at Base to 1 Week
|
131.368 Micrograms per deciliter (ug/dl)
Standard Deviation 480.835
|
20.275 Micrograms per deciliter (ug/dl)
Standard Deviation 389.666
|
PRIMARY outcome
Timeframe: 24 hours - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Interleukin 8 24 Hours to 1 Week
|
168.894 Micrograms per deciliter (ug/dl)
Standard Deviation 548.154
|
-44.42 Micrograms per deciliter (ug/dl)
Standard Deviation 484.019
|
PRIMARY outcome
Timeframe: Baseline- 24hrsMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Tumor Necrosis Factor Alpha at Base to 24 Hours
|
37.526 Micrograms per deciliter (ug/dl)
Standard Deviation 1.266
|
-0.17 Micrograms per deciliter (ug/dl)
Standard Deviation 1.589
|
PRIMARY outcome
Timeframe: Baseline - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Tumor Necrosis Factor Alpha at Base to 1 Week
|
1.5833 Micrograms per deciliter (ug/dl)
Standard Deviation 5.665
|
-0.0704 Micrograms per deciliter (ug/dl)
Standard Deviation 2.8536401
|
PRIMARY outcome
Timeframe: 24hrs - 1 weekMeasuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week
|
1.641 Micrograms per deciliter (ug/dl)
Standard Deviation 5.7217
|
0.095 Micrograms per deciliter (ug/dl)
Standard Deviation 3.633
|
SECONDARY outcome
Timeframe: BaselineUsing the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system: 0= normal gingival without signs of inflammation, no inflammation, no bleeding 1. minor inflammation , slight discoloration, minor surface alterations, no bleeding 2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure 3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Gingival index score of 1.5
|
4 participants
|
8 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Gingival index score of 1.75
|
1 participants
|
2 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Gingival index score of 0.50
|
1 participants
|
0 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Gingival index score of 1
|
0 participants
|
0 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Gingival index score of 1.25
|
18 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 24 hoursUsing the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system: 0= normal gingival without signs of inflammation, no inflammation, no bleeding 1. minor inflammation , slight discoloration, minor surface alterations, no bleeding 2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure 3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Gingival sscore of 0.50
|
1 participants
|
1 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Gingival sscore of 1
|
16 participants
|
4 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Gingival sscore of 1.25
|
6 participants
|
12 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Gingival sscore of 1.50
|
1 participants
|
5 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Gingival sscore of 1.75
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 weekUsing the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system: 0= normal gingival without signs of inflammation, no inflammation, no bleeding 1. minor inflammation , slight discoloration, minor surface alterations, no bleeding 2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure 3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Gingival sscore of 0.50
|
1 participants
|
1 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Gingival sscore of 1
|
2 participants
|
1 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Gingival sscore of 1.25
|
17 participants
|
17 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Gingival sscore of 1.50
|
4 participants
|
3 participants
|
|
Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Gingival sscore of 1.75
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineDepth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations. probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth Score 1
|
0 participants
|
1 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth Score 2
|
3 participants
|
5 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth 3
|
9 participants
|
10 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth 4
|
9 participants
|
6 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth 5
|
3 participants
|
0 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at Baseline
Probing Depth 6
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hoursDepth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations. probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth Score 1
|
1 participants
|
0 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth Score 2
|
5 participants
|
5 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth 3
|
7 participants
|
10 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth 4
|
8 participants
|
6 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth 5
|
2 participants
|
1 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
Probing Depth 6
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 weekDepth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations. probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.
Outcome measures
| Measure |
Simvastatin Group ( Treatment )
n=24 Participants
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Simvastatin: One topical application in peri-implant gingival crevice
|
Control Group
n=22 Participants
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Placebo: One topical application in peri-implant gingival crevice
|
|---|---|---|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth Score 1
|
1 participants
|
0 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth Score 2
|
4 participants
|
4 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth 3
|
8 participants
|
13 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth 4
|
7 participants
|
3 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth 5
|
4 participants
|
2 participants
|
|
Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Probing Depth 6
|
0 participants
|
0 participants
|
Adverse Events
Test Group
Control Group
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