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

Periapical Periodontitis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525013
• Other study ID #: CEBD-CU-2022-8-30
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Mohammed E. Othman Ibrahim, Master's degree
• Phone: 01099762818
• Email: mohamed.essam[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

Drug:
• Simvastatin Powder
Simvastatin gel placed as an intracanal medication
• Calcium Hydroxide
Calcium hydroxide intracanal medication

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)