Trial · NCT03400475
Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
NCT03400475, Phase 2, Completed, Ahmed Mohamed Mahrous; results first posted 2018-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis. Trials, record NCT03400475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03400475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
- NCT number
- NCT03400475
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Ahmed Mohamed Mahrous
- Conditions
- Peri-implant Mucositis
- Interventions
- Simvastatin, Placebo
- First posted
- 2018-01-17
- Last updated
- 2018-12-19
- Results first posted
- 2018-11-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Interleukin 1 B at Base to 24 Hours | Baseline- 24hrs | 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) |
| Primary | Change in Interleukin 1 B at Base to 1 Week | Baseline - 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) |
| Primary | Change in Interleukin 1 B 24 Hours - 1 Week | 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) |
| Primary | Change in Interleukin 6 at Base to 24 Hours | Baseline - 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) |
| Primary | Change in Interleukin 6 Baseline to 1 Week | Baseline - 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) |
| Primary | Change in Interleukin 6 24 Hours - 1 Week | 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) |
| Primary | Change in Interleukin 8 at Base to 24 Hours | Baseline - 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) |
| Primary | Change in Interleukin 8 at Base to 1 Week | Baseline - 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) |
| Primary | Change in Interleukin 8 24 Hours to 1 Week | 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) |
| Primary | Change in Tumor Necrosis Factor Alpha at Base to 24 Hours | Baseline- 24hrs | 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) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Interleukin 1 B at Base to 24 Hours | Baseline- 24hrs | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 1 B at Base to 1 Week | Baseline - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 1 B 24 Hours - 1 Week | 24 hours - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 6 at Base to 24 Hours | Baseline - 24 hours | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 6 Baseline to 1 Week | Baseline - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 6 24 Hours - 1 Week | 24 hours - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 8 at Base to 24 Hours | Baseline - 24 hours | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 8 at Base to 1 Week | Baseline - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Interleukin 8 24 Hours to 1 Week | 24 hours - 1 week | Micrograms per deciliter (ug/dl) | MEAN | |
| PRIMARY | Change in Tumor Necrosis Factor Alpha at Base to 24 Hours | Baseline- 24hrs | Micrograms per deciliter (ug/dl) | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Interleukin 1 B at Base to 24 Hours | Simvastatin Group ( Treatment ) | -1.075 | Standard Deviation 15.587 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 1 B at Base to 24 Hours | Control Group | 1.013 | Standard Deviation 5.273 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 1 B at Base to 1 Week | Simvastatin Group ( Treatment ) | 2.5016 | Standard Deviation 15.4701 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 1 B at Base to 1 Week | Control Group | -1.095 | Standard Deviation 8.6050 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 1 B 24 Hours - 1 Week | Simvastatin Group ( Treatment ) | 3.577 | Standard Deviation 14.137 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 1 B 24 Hours - 1 Week | Control Group | -2.108 | Standard Deviation 10.569 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 6 at Base to 24 Hours | Simvastatin Group ( Treatment ) | 0.118 | Standard Deviation 0.954 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 6 at Base to 24 Hours | Control Group | 0.201 | Standard Deviation 0.880 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 6 Baseline to 1 Week | Simvastatin Group ( Treatment ) | 0.304 | Standard Deviation 1.3744 | Micrograms per deciliter (ug/dl) | |
| Change in Interleukin 6 Baseline to 1 Week | Control Group | 0.275 | Standard Deviation 1.296 | Micrograms per deciliter (ug/dl) |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Group | 24 | |
| Overall Study | STARTED | Control Group | 22 | |
| Overall Study | COMPLETED | Test Group | 24 | |
| Overall Study | COMPLETED | Control Group | 22 | |
| Overall Study | NOT COMPLETED | Test Group | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Test Group | 0 | 24 |
| Total, other adverse events | Control Group | 0 | 22 |
| Total, serious adverse events | Test Group | 0 | 24 |
| Total, serious adverse events | Control Group | 0 | 22 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Test Group vs Control Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03400475
GET https://conductscience.org/api/trials/v1/NCT03400475/results?page=2