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CTRI Number  CTRI/2025/05/087796 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study the effect of new intracanal medicament to reduce pain during root canal treatment 
Scientific Title of Study   Comparative Evaluation Of Three Different Intracanal Medicaments On The Interappointment Pain: A Randomized Clinical Trial Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Labdhi Maloo 
Designation  Post Graduate Student, Department of Conservative Dentistry and Endodontics 
Affiliation  Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon 491441 
Address  Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh Rajnandgaon CHHATTISGARH 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7744939695  
Fax    
Email  labdhimaloo28235@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Labdhi Maloo 
Designation  Post Graduate Student, Department of Conservative Dentistry and Endodontics 
Affiliation  Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon 491441 
Address  Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh Rajnandgaon CHHATTISGARH 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7744939695  
Fax    
Email  labdhimaloo28235@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Nair 
Designation  Head of the Department of Conservative Dentistry and Endodontics 
Affiliation  Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon 491441 
Address  Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh Rajnandgaon CHHATTISGARH 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9630145664  
Fax    
Email  rashmi.a.nair@gmail.com  
 
Source of Monetary or Material Support  
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh Rajnandgaon CHHATTISGARH 491441 India  
 
Primary Sponsor  
Name  Dr Labdhi Maloo 
Address  Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh Rajnandgaon CHHATTISGARH 491441 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Labdhi Maloo  Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon  Room No. 5, Department of Conservative Dentistry and Endodontics, Chhattisgarh Dental College and Research Institute, Sundra
Rajnandgaon
CHHATTISGARH 
7744939695

labdhimaloo28235@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calcium Hydroxide  Premixed calcium hydroxide paste will be placed for 2 weeks 
Intervention  Ferumoxytol  25gm of Ferumoxytol will be mixed with 1 ml of normal saline will be placed for 2 weeks 
Intervention  Modified Triple antibiotic paste   Powdered Clindamycin, Metronidazole, Ciprofloxacin in 1:1:1 ratio mixed with normal saline in 3:1 ratio will be Placed for 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Clinical and Radiographic Evaluation  4, 12, 24, and 48 hours 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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