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OpenTrials
Completed

NCT Number: NCT05525013

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

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:

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Cairo University

Cairo, 52431, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simvastatin Powder

Drug

Simvastatin gel placed as an intracanal medication

Calcium hydroxide

Drug

Calcium hydroxide intracanal medication

Primary outcomes

  1. Post operative pain incidence and intensity assessed with numerical rating scale

    Time frame: 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation

    0 (none) to 10 (severe) Numerical Pain Rating Scale

Secondary outcomes

  1. Total amount of IL-6 and IL-8 in periapical fluids

    Time frame: Immediately post-instrumentation and pre-obturation (1 week post- instrumentation)

    Absorbance using ELISA test in Pg/ml

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Simvastatin Versus Calcium Hydroxide Used as Intracanal Medicaments on Post-operative Pain and Total Amount of IL-6 and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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