Evaluation of the levels of immune response in teeth that have undergone cell death after placing simvastatin as an root canal medicine.

Phase 4

Completed

• Conditions: Necrosis of pulp,

• Registration Number: CTRI/2022/08/044749
• Lead Sponsor: SRM Dental College

Brief Summary

This study is a triple-blinded randomized controlled clinical trial aimed to compare and evaluate the levels of interleukin-6 in teeth with pulp necrosis and symptomatic apical periodontitis following placement of simvastatin as an intracanal medicament conducted in Chennai, India with the primary outcome measure being a 10% increased efficacy of simvastatin in reduction of Interleukin -6 levels compared to calcium hydroxide after a period of 7 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Study Completion: 2023-12-26
• Last Update Posted: 2024-05-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

ASA score 1 Healthy patients aged 16-60 years patients diagnosed with pulpal necrosis and symptomatic apical periodontitis (PAI ≤2) Single rooted teeth with single canal and closed apex.

Exclusion Criteria

• Patients under ASA 2-5 category.
• Patients under any medication for a week.
• Patients with periapical pathology (PAI score >2) Teeth with cracks, vertical root fracture, internal & external resorption.
• Multirooted teeth, Single rooted teeth with multiple canals.
• Teeth with immature apex.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification and comparison of	Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement.
placement of simvastatin will show	Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement.
Interleukin-6 before and after	Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement.
decrease in its concentration	Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement.

Secondary Outcome Measures

Name	Time	Method
Quantification and comparison of	Interleukin-6 before and after

Trial Locations

Locations (1)

SRM Dental College; 🇮🇳 Chennai, TAMIL NADU, India

SRM Dental College

🇮🇳Chennai, TAMIL NADU, India

Dr Nikhil Harikrishnan

Principal investigator

9400430067

nikhilmeloth@gmail.com