Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8

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Description

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:

Targeted Conditions

Study Overview

Start Date
October 1, 2022
Completion Date
November 1, 2024
Enrollment
30
Date Posted
September 1, 2022
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Faculty of Dentistry - Cairo University
Cairo 52431, Egypt

Eligibility

Minimum Age (years)
20
Maximum Age (years)
45
Eligibility Criteria
Inclusion Criteria:

Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.

Lower single rooted premolars:

Presence of pain with percussion.
Widening in the periodontal membrane space or with small sized periapical radiolucency.
Diagnosed clinically with symptomatic apical periodontitis.
Patients' acceptance to participate in the trial.
Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

Medically compromised patients
Pregnant women
Patients who are allergic to non-steroidal anti-inflammatory drugs.
Patients with two or more adjacent teeth requiring root canal therapy
If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
Patients reporting bruxism or clenching.
Teeth associated with acute periapical abscess, swelling or a fistulous tract.
Greater than grade I mobility or pocket depth greater than 5mm.
Non restorable teeth.
Immature teeth.
Teeth with previous endodontic treatment.
Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Study Contact Info

Study Contact Name
Mohammed E. Othman Ibrahim, Master's degree; Faculty of Dentistry Cairo university
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
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.
NCTid (if applicable)
NCT05525013