| 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 |
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
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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.
|
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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.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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" |
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |