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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Simvastatin

Simvastatin as an intracanal medication

Group Type EXPERIMENTAL

Simvastatin Powder

Intervention Type DRUG

Simvastatin gel placed as an intracanal medication

Calcium hydroxide

Calcium hydroxide intracanal medication

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type DRUG

Calcium hydroxide intracanal medication

Interventions

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Simvastatin Powder

Simvastatin gel placed as an intracanal medication

Intervention Type DRUG

Calcium Hydroxide

Calcium hydroxide intracanal medication

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes