Antimicrobial and Anti-inflammatory Effects of Simvastatin as an Intracanal Medication
1 other identifier
interventional
54
1 country
1
Brief Summary
Successful endodontic treatment and a predictable outcome can only be achieved by effective root canal debridement, irrigation, and elimination of microorganisms . The outcome of endodontic treatment performed in controlled clinical environment has demonstrated success rate around 90%. In certain cases, endodontic treatment may fail, one of the most common reasons is inability to eliminate microorganisms from the root canal. When non-surgical root canal therapy fails, the treatment options include orthograde re-treatment, periradicular surgery, or extraction. Simvastatin (SIM) is a drug used primarily to treat hyperlipidemia and protect against cardiovascular diseases. It has been shown to possess pleiotropic effects such as antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and bone-forming properties . The side chain of this material has a single methyl group. It inhibits hydroxymethyl glutarylcoenzyme reductase that prevents endogenous cholesterol synthesis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 10, 2026
December 1, 2025
August 1, 2025
12 months
November 20, 2025
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Simvastatin antimicrobial effect
Following the treatment, patients will be asked to evaluate The antimicrobial effect of Simvastatin intracanal medication
6 Months
Secondary Outcomes (1)
Simvastatin anti-inflammatory effect
6 Months
Study Arms (2)
Simvastatin Group
ACTIVE COMPARATORAbout 27 Patients will take Simvastatin 10mg tablets which will be crushed into fine particles and dissolved to prepare an intracanal medication with specific concentration according to the antimicrobial sensitivity study.
Calcium hydroxide
ACTIVE COMPARATORAbout 27 Patients will be injected by Calcium hydroxide intracanal medication in endodontic retreatment of single rooted teeth with periapical radiolucency.
Interventions
to evaluate the antimicrobial and anti-inflammatory effects of Simvastatin as an intracanal medication in endodontic retreatment of single rooted teeth with periapical radiolucency.
Eligibility Criteria
You may qualify if:
- Patients had anon contributory medical history.
- Patients of age categories between 20 to 40 years old, with no physical disability or psychological problems.
- Single rooted teeth with type I root canal anatomy.
- Symptomatic cases of failed endodontic treatment with radiographic evidence of periapical bone loss, and the lesion size ranging from 2mm up to 8mm.
You may not qualify if:
- Patients with known sensitivity to the pharmaceutical used in this trial
- Patients with former endodontic mishaps (as ledges, transportations, perforations or separated instruments)
- Non restorable teeth
- Presence of an associated sinus tract.
- Advanced periodontal involvement
- Teeth representing root fracture.
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mervat Ibrahim Fawzy, Professor
Faculty of Dental Medicine for Girls Al Azhar University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer of Endodontics at Suez University
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 1, 2025
Study Start
August 10, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 10, 2026
Last Updated
December 1, 2025
Record last verified: 2025-08