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CTRI Number  CTRI/2024/10/075706 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of three different root canal irrigants against E Faecalis in pulpectomy procedure of primary molars 
Scientific Title of Study   EVALUATION OF 3.8 PERCENTAGE SDF, MTAD AND 1 PERCENTAGE NaOCl AS ROOT CANAL IRRIGANTS AGAINST E. faecalis IN PULPECTOMIZED PRIMARY TEETH: A CLINICAL TRIAL 
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 Murshid Babu P 
Designation  Post graduate 
Affiliation  KVG Dental college and hospital  
Address  Room No 10 Department of Pediatric and Preventive Dentistry KVG Dental College and Hospital Sullia Dakshina Kannada karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7795695439  
Fax    
Email  murshidb17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnamoorthy S H 
Designation  Professor 
Affiliation  KVG Dental college and hospital  
Address  Room No 10 Department of Pediatric and Preventive Dentistry KVG Dental College and Hospital Sullia Dakshina Kannada karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9964428004  
Fax    
Email  kmoorthysh21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnamoorthy S H 
Designation  Professor 
Affiliation  KVG Dental college and hospital  
Address  Room No 10 Department of Pediatric and Preventive Dentistry KVG Dental College and Hospital Sullia Dakshina Kannada karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9964428004  
Fax    
Email  kmoorthysh21@gmail.com  
 
Source of Monetary or Material Support  
KVG Dental college and Hospital Sullia DK Karnataka India 574327 
 
Primary Sponsor  
Name  Dr Murshid Babu P 
Address  Room 10 Department of Pediatric and Preventive dentistry KVG Dental college and hospital Sullia, DK, Karnataka 
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 Murshid Babu P  KVG Dental College and Hospital  Room No 10 Department of Pediatric and Preventive dentistry KVG dental college and Hospital Sullia
Dakshina Kannada
KARNATAKA 
7795695439

murshidb17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KVG dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1% NaOCl as root canal irrigant against E.faecalis  22 teeth will be irrigated with 0.5 mL of 1 % NaOCl at each filing. The canal will be irrigated for the final time after instrumentation and before obturation. Post-instrumentation sampling from the distal canal will be performed using a No. 20 size clean absorbent paper point for 30 seconds, ensuring it reaches the specified working length. The canal will then be obturated using Zinc Oxide and Eugenol (ZOE) obturating material, and an intraoral periapical radiograph will be taken after the procedure. Then tooth will be restored with glass ionomer cement followed by stainless steel crown. The duration of the procedure will be 40minutes. 
Intervention  3.8% SDF as root canal irrigant against E.faecalis  22 teeth will be irrigated with 0.5 mL of 3.8% SDF at each filing. The canal will be irrigated for the final time after instrumentation and before obturation.Post- instrumentation sampling from the distal canal will be performed using a No. 20 size clean absorbent paper point for 30 seconds, ensuring it reaches the specified working length. The canal will then be obturated using Zinc Oxide and Eugenol (ZOE) obturating material, and an intraoral periapical radiograph will be taken after the procedure. Then tooth will be restored with glass ionomer cement followed by stainless steel crown.The duration of the procedure will be 40minutes. 
Comparator Agent  MTAD as root canal irrigant against E.faecalis  22 teeth will be irrigated with 0.5 mL of MTAD at each filing. The canal will be irrigated for the final time after instrumentation and before obturation. Post- instrumentation sampling from the distal canal will be performed using a No. 20 size clean absorbent paper point for 30 seconds, ensuring it reaches the specified working length. The canal will then be obturated using Zinc Oxide and Eugenol (ZOE) obturating material, and an intraoral periapical radiograph will be taken after the procedure. Then tooth will be restored with glass ionomer cement followed by stainless steel crown.The duration of the procedure will be 40minutes.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children aged 3 to 8 years requiring pulpectomy for primary molars diagnosed with irreversible pulpitis.
No notable medical conditions present.
No exposure to antibiotics within the preceding three months.
Primary teeth with sufficient coronal and at least two-thirds root structure.
Absence of sinus tracts and pathological root resorption.
 
 
ExclusionCriteria 
Details  Patients who have taken antibiotics within three months.
Patients diagnosed with any systemic diseases.
Patients with non-restorable teeth, perforated pulpal floors, excessive mobility, or pathological root resorption.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyze and compare anti-microbial effectiveness of 3.8% SDF, MTAD, and 1% NaOCl in pulpectomised primary root canals.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Quantitative assessment of E. faecalis in the root canals of pulpectomized primary molars after extirpation of pulp as baseline.
Quantitative assessment of E. faecalis post irrigation using 3.8% SDF, MTAD and 1% NaOCl as irrigants in the distal root of pulpectomized primary teeth. 
6 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   Phase 3 
Date of First Enrollment (India)   01/02/2025 
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  

Primary teeth are vital for a child’s dental and facial development, serving important functions like chewing, speech, and maintaining occlusion until permanent teeth emerge. However, conditions such as dental caries can progress to irreversible pulpitis or pulp necrosis, often accompanied by abscess formation, which are common in pediatric dentistry. In some cases, primary teeth may exhibit signs of both simultaneously. The presence of accessory canals further complicates matters by allowing infective agents to spread into bone marrow spaces and around the developing tooth, undermining the success of endodontic therapy. Inadequate cleaning can result in the persistence of microorganisms and their byproducts, significantly increasing the risk of treatment failure. Thorough removal of pulpal tissues, dentinal debris, and viable microorganisms is vital in endodontic treatment. Complete elimination of microbes is necessary for successful therapy. Inadequate removal can lead to persistent inflammation, hindering healing and compromising treatment effectiveness. Meticulous cleaning and disinfection are essential for optimal outcomes.2 While sufficient instrumentation and irrigation with NaOCl can reduce bacterial counts, but they may not fully eliminate E. faecalis from the root canal.3In cases of post-endodontic therapy pain and infection, E. faecalis is frequently identified,With the prevalence rates reaching up to 90%.This microorganism, characterized as non-fastidious and therapy-resistant, poses challenges in treating infected root canals.Intracanal irrigants play a crucial role in enhancing mechanical debridement by facilitating debris removal, tissue dissolution, and disinfection if canals. The intricate internal anatomy of primary teeth emphasizes the importance of efficient irrigation for thorough cleaning and disinfection.Past efforts to eliminate E. faecalis biofilm with traditional irrigants have been limited. Despite the use of conventional disinfectants and medicaments, achieving and maintaining sterilization of root canals has remained challenging. Intracanal irrigation using a 3.8% w/v solution of SDF, a diluted variant of the SDF used for root canal treatment, has shown promise. Research indicates that 3.8% SDF exhibits antibacterial properties against E. faecalis biofilm and can effectively reduce bacteria as a root canal irrigant. SDF has a high capacity for fluoride release and anti-cariogenic properties, which make it effective for pediatric dentistry. MTAD (a mixture of tetracycline isomer, an acid, and a detergent) has been introduced by Torabinejad and Johnson, is a disinfectant for the root canal system. It consists of a 3% doxycycline aqueous solution, acting as a broad-spectrum antibiotic; 4.25% citric acid, serving as a demineralizing agent; and 0.5% polysorbate 80 detergent (Tween 80). Studies have shown MTAD’s clinical effectiveness and biocompatibility as an endodontic irrigant, equivalent to NaOCl.Sodium hypochlorite (NaOCl), commonly used in root canal treatment, effectively dissolves organic substances but has drawbacks. Its advantages include affordability and organic dissolution capability. However, drawbacks of NaOCl include cytotoxicity, foul odor, clothing bleaching, metal corrosion, incomplete bacterial eradication, smear layer retention, dentin property alteration, and reduced antimicrobial effectiveness over time due to exposure to oxygen, room temperature, and light. So, this study will be aimed to assess and compare the efficacy of 3.8% SDF, MTAD, and 1 % NaOCl as irrigants against Enterococcus faecalis in root canals of pulpectomized primary teeth through an in vivo investigation.

 
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