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

Cairo University (CU)

Status: Completed

Conditions: Periapical Periodontitis

Treatments: Drug: Simvastatin Powder; Drug: Calcium Hydroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT05525013

CEBD-CU-2022-8-30

Details and patient eligibility

About

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:

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 two weeks 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Simvastatin

Experimental group

Description:

Simvastatin as an intracanal medication

Treatment:

Drug: Simvastatin Powder

Calcium hydroxide

Active Comparator group

Description:

Calcium hydroxide intracanal medication

Treatment:

Drug: Calcium Hydroxide