To Study the effect of new intracanal medicament to reduce pain during root canal treatment
- Conditions
- Acute apical periodontitis of pulpal origin,
- Registration Number
- CTRI/2025/05/087796
- Lead Sponsor
- Dr Labdhi Maloo
- Brief Summary
The present study titled **Comparative Evaluation of Three Different Intracanal Medicaments on the Interappointment Pain: A Randomized Clinical Trial Study** is a single center, randomized, parallel group, in vivo clinical trial being conducted at Chhattisgarh Dental College and Research Institute, Rajnandgaon. The primary objective of the study is to compare the effectiveness of three intracanal medicaments **Calcium Hydroxide**, **Modified Triple Antibiotic Paste (mTAP)**, and **Ferumoxytol**, in reducing interappointment pain in patients undergoing endodontic treatment. Pain during the interval between endodontic appointments remains a significant clinical concern, often attributed to persistent bacterial infection within the root canal system. Although calcium hydroxide is widely used as an intracanal medicament, its limitations, such as inefficacy against resistant strains like *Enterococcus faecalis*, necessitate exploring alternative agents. Modified TAP, which substitutes minocycline with cefaclor to prevent tooth discoloration, has demonstrated enhanced antimicrobial properties. Recently, **Ferumoxytol**, an FDA-approved iron oxide nanoparticle with peroxidase like activity, has emerged as a potential novel intracanal medicament due to its biofilm-disrupting capabilities.
A total of 45 patients aged between 18 and 55 years, with single rooted maxillary or mandibular teeth indicated for root canal treatment, will be recruited and randomly assigned to one of the three study groups n-15 per group using the lottery method. The assigned intracanal medicament will be placed following standardized biomechanical preparation of the canals. Pain intensity will be evaluated using the **Numerical Rating Scale (NRS)** at 4, 12, 24, and 48 hours post-treatment. Final obturation will be carried out on the seventh day. The evaluator assessing the pain outcomes will be blinded to the group allocation to eliminate assessment bias. Data will be statistically analyzed using ANOVA with post hoc Tukey tests, and significance will be determined at *p value more than 0.05*.
This study aims to generate clinical evidence on the comparative efficacy of conventional and novel intracanal medicaments in managing postoperative endodontic pain, with particular emphasis on Ferumoxytol, which is being investigated in this context for the first time. The outcome may inform future protocols in root canal disinfection and pain management. Ethical clearance has been obtained, and informed consent will be taken from all participants before enrollment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 45
- Single-rooted Maxillary/Mandibular teeth.
- Non-contributory medical history (patient can be seen for regular dental appointments).
- Tooth with adequate remaining tooth structure for proper isolation with a rubber dam.No history of previous endodontic treatment on the tooth.Clinical examination: Teeth with response to pain and suggestive of Tenderness on percussion positive.
- Radiographic examination: Teeth in which lesion involving pulp, loss of lamina dura, and widening of PDL space.
- Immunocompromised Patients, self-reported pregnancy, patients with multiple drug allergies.
- Patients with known hypersensitivity to ferumoxytol nanoparticles or any iron products.
- Patients who are scheduled for MRI for the head region within three months after Fer nanoparticles application.
- Periodontal changes.
- Radiographic presence of resorptive processes.
- Teeth with sinus opening, mobility, cracked tooth, furcal radiolucency, internal or external resorption, and periapical lesion.
- Adverse reaction reported to any dental material.
- Uncooperative patient.
- If one of the inclusion criteria is not met.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome is to compare and evaluate three different intracanal medicaments and their interappointment pain pain at 4, 12, 24, and 48 hours 4, 12, 24, and 48 hours
- Secondary Outcome Measures
Name Time Method Clinical and Radiographic Evaluation 4, 12, 24, and 48 hours
Trial Locations
- Locations (1)
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
🇮🇳Rajnandgaon, CHHATTISGARH, India
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon🇮🇳Rajnandgaon, CHHATTISGARH, IndiaDr Labdhi MalooPrincipal investigator7744939695labdhimaloo28235@gmail.com