Antimicrobial and Anti-inflammatory Effects of Simvastatin as an Intracanal Medication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorHadeer Maher Mostafa Mohamed
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Simvastatin as an intracanal medication
Procedure/Surgeryto evaluate the antimicrobial and anti-inflammatory effects of Simvastatin as an intracanal medication in endodontic retreatment of single rooted teeth with periapical radiolucency.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Simvastatin GroupActive comparator 1 intervention
Group B: Calcium hydroxideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Simvastatin antimicrobial effect
Following the treatment, patients will be asked to evaluate The antimicrobial effect of Simvastatin intracanal medication
Time frame
6 MonthsSecondary outcomes
1
Simvastatin anti-inflammatory effect
Following the treatment, patients will be asked to evaluate The anti-inflammatory effect of Simvastatin intracanal medication and periapical radiolucency healing.
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hadeer Maher Mostafa Mohamed
Lead sponsor
Faculty of Dental Medicine for Girls
Sponsor institution
Source ClinicalTrials.gov