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
|
|
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
|
|
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. |