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Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis:
Lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. The endodontic treatment will be completed in two visits. Postoperative pain will be assessed using the Numerical Rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. Periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. The periapical samples will be analyzed for total amounts of IL-6 and IL-8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Experimental | Simvastatin as an intracanal medication |
|
| Calcium hydroxide | Active Comparator | Calcium hydroxide intracanal medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin Powder | Drug | Simvastatin gel placed as an intracanal medication |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain incidence and intensity assessed with numerical rating scale | 0 (none) to 10 (severe) Numerical Pain Rating Scale | 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of IL-6 and IL-8 in periapical fluids | Absorbance using ELISA test in Pg/ml | Immediately post-instrumentation and pre-obturation (1 week post- instrumentation) |
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Inclusion Criteria:
Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
Lower single rooted premolars:
Patients' acceptance to participate in the trial.
Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Cairo University | Cairo | 52431 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18928847 | Background | Khan AA, Sun X, Hargreaves KM. Effect of calcium hydroxide on proinflammatory cytokines and neuropeptides. J Endod. 2008 Nov;34(11):1360-1363. doi: 10.1016/j.joen.2008.08.020. Epub 2008 Sep 17. | |
| 35012572 | Background | Sharma A, Sanjeev K, Selvanathan VMJ, Sekar M, Harikrishnan N. The evaluation of cytotoxicity and cytokine IL-6 production of root canal sealers with and without the incorporation of simvastatin: an invitro study. BMC Oral Health. 2022 Jan 11;22(1):6. doi: 10.1186/s12903-022-02039-y. |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
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A Computerized random sequence will be generated using computer software (http://www.random.org/). The sequence generation will be done for the patients' numbers which results in a sequence of random numbers divided in two columns (A & B), where one column assigned for the intervention groups and one for the control group and kept with the co- supervisor. The patients will be allocated into either of the two groups with allocation ratio 1:1
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After the participant is confirmed eligible for the study, the participant will drag an envelope and will be given a number. Based on this number the patient will be allocated to either intervention or control group after contacting the co- supervisor to reveal the assigned group of the current patient according to the generated random sequence.
| Calcium Hydroxide |
| Drug |
Calcium hydroxide intracanal medication |
|
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |