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

NCT05525013 | Completed

• 1 other identifier: CEBD-CU-2022-8-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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:

Conditions

Periapical Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total amount of IL-6 and IL-8 in periapical fluids

  Immediately post-instrumentation and pre-obturation (1 week post- instrumentation)

Study Arms (2)

Simvastatin

EXPERIMENTAL

Simvastatin as an intracanal medication

Drug: Simvastatin Powder

Calcium hydroxide

ACTIVE COMPARATOR

Calcium hydroxide intracanal medication

Drug: Calcium Hydroxide

Interventions

Simvastatin Powder DRUG

Simvastatin gel placed as an intracanal medication

Simvastatin

Calcium Hydroxide DRUG

Calcium hydroxide intracanal medication

Calcium hydroxide

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, 52431, Egypt

Location

Related 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.

  PMID: 18928847 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.

  PMID: 35012572 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Model Details: 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

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)