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| Name | Class |
|---|---|
| Greater New York Academy of Prosthodontics | UNKNOWN |
| American College of Prosthodontists Education Foundation | UNKNOWN |
| University of Iowa | OTHER |
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This study seeks to test the recently discovered anti-inflammatory action of statins on inflamed mucosa surrounding dental implants.
Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation.
The pilot study will involve 44 subjects divided into a test and control group. The test group shall receive topical simvastatin gel administered around the implant with a blunt tipped needle. The control group will receive a placebo.
Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1 week, and 1 month by clinical indices of inflammation as well as biochemical markers of inflammation gathered from around the implants.
Following signing the consent document the following will occur:
Screening Patients will complete standard medical and dental health history forms, followed by a study specific screening questionnaire. if the patient is deemed eligible, the patient will be examined clinically. The clinical examination will include diagnostic procedures typical of an implant recall visit. Initially, the sulcus will be probed with a periodontal probe; if bleeding on probing is elicited, then a radiograph will be made.
The following shall be done to screen the patients:
If the patient exhibits no bleeding on probing, or signs of mesial/distal bone loss greater than 1mm from the accepted reference point on the implant system the patient will be excluded from the study.
Subject allocation
Subjects will be assigned with equal allocation into the following groups:
Baseline measurements Baseline measurements will be made at least 48 hours after screening (allowing time for complete hemostasis of peri-implant crevicular mucosa after bleeding induced by probing in the screening visit).
Following baseline measurements, Test and Control interventions will be administered.
The baseline measurements include the following:
Peri-implant crevicular fluid (PICF) collection: Each implant site will be isolated with cotton rolls and light air will be applied over the side to eliminate ambient salivary contamination of the PICF sample. Sampling will be done using paper strips that are inserted with cotton forceps into the gingival crevice until mild resistance is felt. After gingival crevicular fluid (GCF) collection, the volumes are immediately quantified using the Periotron 8000 instrument.
Gingival Index: Using 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
Probing depth: Measured by a calibrated periodontal probe at 6 different locations, mesiobuccal, midbuccal, distobuccal, distolingual, midlingual, and mesiolingual.
Administration of test and control intervention will be delivered into the peri- implant gingival sulcus using a plastic syringe with a blunt cannula following baseline measurements. 0.1ml of gel will be administered with a blunt cannula evenly distributed in the peri-implant sulcus. The investigator will not know whether the subject is receiving the active or control intervention.
Recall appointments and measurements Both Test and Control subjects will be scheduled recall visits. Recalls will be done at 24 hours (+ or - 3 hours), 1 week (+ or - 12 hours), and 1 month (+ or - 11 days).
On each recall visit, the following procedures will take place:
Cytokine analysis Due to study constraints, not all PICF samples collected from subjects will be analyzed in the pilot study. The samples that will be analyzed will be selected randomly from the study population. Cytokine samples from only 13 randomly selected subjects from the test group, as well as 13 randomly selected subjects from the control group will be analyzed. Of these randomly selected samples, only those collected at baseline, 24 hours, and at 1 week will be analyzed. The remaining cytokine samples will be evaluated as part of a later study. Cytokine quantities will be determined using; a commercial 22 multipixed fluorescent bead based immunoassay and luminex 100 IS instrument. The kit used is the MILLIPLEX map Human Cytokine/ Chemokine Magnetic Bead Panel- Immunology Multiplex Assay (HCYTOMAG-60K) capable of detecting IL-1Beta;, TNF-Alpha;, IL-6, IL-8.
The study in total will take 1 month and 2 days. All visits will generally take 0.5-1.5 hours. No long term follow up will be required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin group (Treatment) | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | One topical application in peri-implant gingival crevice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin 1 B at Base to 24 Hours | 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) | Baseline- 24hrs |
| Change in Interleukin 1 B at Base to 1 Week | 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) | Baseline - 1 week |
| Change in Interleukin 1 B 24 Hours - 1 Week | 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) | 24 hours - 1 week |
| Change in Interleukin 6 at Base to 24 Hours | 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) | Baseline - 24 hours |
| Change in Interleukin 6 Baseline to 1 Week | 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) | Baseline - 1 week |
| Change in Interleukin 6 24 Hours - 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline | Using 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
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Mahrous, B.D.S., M.S. | University of Iowa College of Dentistry and Dental Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry and Dental Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20151799 | Background | Pradeep AR, Thorat MS. Clinical effect of subgingivally delivered simvastatin in the treatment of patients with chronic periodontitis: a randomized clinical trial. J Periodontol. 2010 Feb;81(2):214-22. doi: 10.1902/jop.2009.090429. | |
| 16955604 | Background | Liskmann S, Vihalemm T, Salum O, Zilmer K, Fischer K, Zilmer M. Correlations between clinical parameters and interleukin-6 and interleukin-10 levels in saliva from totally edentulous patients with peri-implant disease. Int J Oral Maxillofac Implants. 2006 Jul-Aug;21(4):543-50. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
each patient is considered one unit
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Interleukin 1 B at Base to 24 Hours | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline- 24hrs |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmed Mahrous | University of Iowa | 3193336517 | ahmedmohamed-mahrous@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2014 | Dec 15, 2017 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D054709 | Lecithins |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
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Only the study coordinator will know whether the intervention is simvastatin or control.
| Placebo | Other | One topical application in peri-implant gingival crevice |
|
|
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)
| 24 hours - 1 week |
| Change in Interleukin 8 at Base to 24 Hours | 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) | Baseline - 24 hours |
| Change in Interleukin 8 at Base to 1 Week | 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) | Baseline - 1 week |
| Change in Interleukin 8 24 Hours to 1 Week | 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) | 24 hours - 1 week |
| Change in Tumor Necrosis Factor Alpha at Base to 24 Hours | 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) | Baseline- 24hrs |
| Change in Tumor Necrosis Factor Alpha at Base to 1 Week | 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) | Baseline - 1 week |
| Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week | 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) | 24hrs - 1 week |
| Baseline |
| Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours | Using 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
| 24 hours |
| Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week | Using 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 week |
| Probing Depth Level (Averaged Over 6 Sites) at Baseline | Depth 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. | Baseline |
| Probing Depth Level (Averaged Over 6 Sites) at 24 Hours | Depth 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. | 24 hours |
| Probing Depth Level (Averaged Over 6 Sites) at 1 Week | Depth 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. | 1 week |
| 16642902 | Background | Konttinen YT, Lappalainen R, Laine P, Kitti U, Santavirta S, Teronen O. Immunohistochemical evaluation of inflammatory mediators in failing implants. Int J Periodontics Restorative Dent. 2006 Apr;26(2):135-41. |
| 16723648 | Background | Sakoda K, Yamamoto M, Negishi Y, Liao JK, Node K, Izumi Y. Simvastatin decreases IL-6 and IL-8 production in epithelial cells. J Dent Res. 2006 Jun;85(6):520-3. doi: 10.1177/154405910608500608. |
| 22592038 | Background | Guncu GN, Akman AC, Gunday S, Yamalik N, Berker E. Effect of inflammation on cytokine levels and bone remodelling markers in peri-implant sulcus fluid: a preliminary report. Cytokine. 2012 Aug;59(2):313-6. doi: 10.1016/j.cyto.2012.04.024. Epub 2012 May 14. |
| 19302394 | Background | Duarte PM, de Mendonca AC, Maximo MB, Santos VR, Bastos MF, Nociti Junior FH. Differential cytokine expressions affect the severity of peri-implant disease. Clin Oral Implants Res. 2009 May;20(5):514-20. doi: 10.1111/j.1600-0501.2008.01680.x. Epub 2009 Mar 11. |
| 10933353 | Background | Ferro D, Parrotto S, Basili S, Alessandri C, Violi F. Simvastatin inhibits the monocyte expression of proinflammatory cytokines in patients with hypercholesterolemia. J Am Coll Cardiol. 2000 Aug;36(2):427-31. doi: 10.1016/s0735-1097(00)00771-3. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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
|
|
|
| Primary | Change in Interleukin 1 B at Base to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 1 week |
|
|
|
|
| Primary | Change in Interleukin 1 B 24 Hours - 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | 24 hours - 1 week |
|
|
|
|
| Primary | Change in Interleukin 6 at Base to 24 Hours | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 24 hours |
|
|
|
|
| Primary | Change in Interleukin 6 Baseline to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 1 week |
|
|
|
|
| Primary | Change in Interleukin 6 24 Hours - 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | 24 hours - 1 week |
|
|
|
|
| Primary | Change in Interleukin 8 at Base to 24 Hours | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 24 hours |
|
|
|
|
| Primary | Change in Interleukin 8 at Base to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 1 week |
|
|
|
|
| Primary | Change in Interleukin 8 24 Hours to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | 24 hours - 1 week |
|
|
|
|
| Primary | Change in Tumor Necrosis Factor Alpha at Base to 24 Hours | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline- 24hrs |
|
|
|
|
| Primary | Change in Tumor Necrosis Factor Alpha at Base to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | Baseline - 1 week |
|
|
|
|
| Primary | Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week | 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) | Posted | Mean | Standard Deviation | Micrograms per deciliter (ug/dl) | 24hrs - 1 week |
|
|
|
|
| Secondary | Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline | Using 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
| Posted | Number | participants | Baseline |
|
|
|
|
| Secondary | Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours | Using 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
| Posted | Number | participants | 24 hours |
|
|
|
|
| Secondary | Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week | Using 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
| Posted | Number | participants | 1 week |
|
|
|
|
| Secondary | Probing Depth Level (Averaged Over 6 Sites) at Baseline | Depth 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Secondary | Probing Depth Level (Averaged Over 6 Sites) at 24 Hours | Depth 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. | Posted | Number | participants | 24 hours |
|
|
|
|
| Secondary | Probing Depth Level (Averaged Over 6 Sites) at 1 Week | Depth 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. | Posted | Number | participants | 1 week |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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 | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D010713 | Phosphatidylcholines |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| Gingival index score of 1.25 |
|
| Gingival index score of 1.5 |
|
| Gingival index score of 1.75 |
|
| Gingival sscore of 1.25 |
|
| Gingival sscore of 1.50 |
|
| Gingival sscore of 1.75 |
|
| Gingival sscore of 1.25 |
|
| Gingival sscore of 1.50 |
|
| Gingival sscore of 1.75 |
|
| Probing Depth 3 |
|
| Probing Depth 4 |
|
| Probing Depth 5 |
|
| Probing Depth 6 |
|
| Probing Depth 3 |
|
| Probing Depth 4 |
|
| Probing Depth 5 |
|
| Probing Depth 6 |
|
| Probing Depth 3 |
|
| Probing Depth 4 |
|
| Probing Depth 5 |
|
| Probing Depth 6 |
|