search
Back to results

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

Primary Purpose

Periapical Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Simvastatin Powder
Calcium Hydroxide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts 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 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.

Sites / Locations

  • Faculty of Dentistry - Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin

Calcium hydroxide

Arm Description

Simvastatin as an intracanal medication

Calcium hydroxide intracanal medication

Outcomes

Primary Outcome Measures

Post operative pain incidence and intensity assessed with numerical rating scale
0 (none) to 10 (severe) Numerical Pain Rating Scale

Secondary Outcome Measures

Total amount of IL-6 and IL-8 in periapical fluids
Absorbance using ELISA test in Pg/ml

Full Information

First Posted
August 30, 2022
Last Updated
November 2, 2022
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05525013
Brief Title
Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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:
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Simvastatin as an intracanal medication
Arm Title
Calcium hydroxide
Arm Type
Active Comparator
Arm Description
Calcium hydroxide intracanal medication
Intervention Type
Drug
Intervention Name(s)
Simvastatin Powder
Intervention Description
Simvastatin gel placed as an intracanal medication
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Intervention Description
Calcium hydroxide intracanal medication
Primary Outcome Measure Information:
Title
Post operative pain incidence and intensity assessed with numerical rating scale
Description
0 (none) to 10 (severe) Numerical Pain Rating Scale
Time Frame
6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation
Secondary Outcome Measure Information:
Title
Total amount of IL-6 and IL-8 in periapical fluids
Description
Absorbance using ELISA test in Pg/ml
Time Frame
Immediately post-instrumentation and pre-obturation (1 week post- instrumentation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed E. Othman Ibrahim, Master's degree
Phone
01099762818
Ext
+02
Email
mohamed.essam@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Faculty of Dentistry Cairo university
Phone
23634965
Ext
+ (202)
Email
dentmail@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry - Cairo University
City
Cairo
ZIP/Postal Code
52431
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Dentistry - Cairo university
Phone
23634965
Ext
+202
Email
dentmail@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18928847
Citation
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.
Results Reference
background
PubMed Identifier
35012572
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs