Simvastatin placed inside the root canal for failed single‑rooted teeth with periapical lesions
Antimicrobial and Anti-inflammatory Effects of Simvastatin as an Intracanal Medication in Endodontically Retreated Teeth With Periapical Radiolucency, Randomized Controlled Clinical Trial
NA · Faculty of Dental Medicine for Girls · NCT07256561
This trial will test whether putting simvastatin into the root canal helps kill bacteria and reduce inflammation in adults (20–40) with single‑rooted failed root canals and periapical radiolucency.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | All |
| Sponsor | Faculty of Dental Medicine for Girls (other gov) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07256561 on ClinicalTrials.gov |
What this trial studies
This interventional study applies simvastatin as an intracanal medication in symptomatic failed endodontic cases of single‑rooted teeth with periapical lesions measuring 2–8 mm in patients aged 20–40. Eligible teeth will be re‑treated and receive simvastatin placed inside the prepared root canal, with follow‑up clinical and radiographic exams to monitor healing. Microbiological targets include Enterococcus faecalis and biofilm reduction, and inflammatory markers such as IL‑1β, TNF‑α, and PGE2 may be measured to document anti‑inflammatory effects. Standard exclusions include pregnancy, non‑restorable teeth, advanced periodontal disease, root fractures, prior endodontic mishaps, and known drug sensitivity.
Who should consider this trial
Good fit: Ideal candidates are medically fit adults aged 20–40 with a symptomatic failed single‑rooted root canal and a 2–8 mm periapical radiolucency who are not pregnant and have restorable teeth.
Not a fit: Patients with multi‑rooted teeth, lesions outside the 2–8 mm range, advanced periodontal disease, root fractures, non‑restorable teeth, prior endodontic mishaps, pregnancy, or known sensitivity to the drug are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, intracanal simvastatin could improve infection control and reduce inflammation, increasing healing rates and potentially avoiding surgery or extraction.
How similar studies have performed: Preclinical and laboratory studies report antimicrobial, anti‑inflammatory, and bone‑forming effects of simvastatin, but clinical intracanal use remains novel with limited human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Cairo
- Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Hadeer Maher Mostafa Mohamed, MSc
- Email: hadeer.maher@den.suezuni.edu.eg
- Phone: +201024990619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endodontically Retard Teeth, Periapical Radiolucency