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CTRI Number  CTRI/2025/10/096149 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Methods of Filling Root Canals in milk Teeth: Indirect Vibration and Handheld Lentulospiral 
Scientific Title of Study   Comparative Evaluation Of Root Canal Obturation In Primary Teeth Using A Novel Method Of Indirect Vibration And Handheld Lentulospiral Technique : An In Vivo 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  Maheswari Ambi 
Designation  PG Student 
Affiliation  Maratha Mandals Dental College and Research Centre Karnataka 
Address  47 A/2,BAUXITE ROAD,NEAR KSRP GROUND, BELGAVI

Belgaum
KARNATAKA
590010
India 
Phone  07899245025  
Fax    
Email  maheshwariambi9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shruti Virupaxi 
Designation  PG Student 
Affiliation  Maratha Mandals Dental College and Research Centre Karnataka 
Address  DEPT OF PEDODONTICS,47 A/2,BAUXITE ROAD,NEAR KSRP GROUND, BELGAVI

Belgaum
KARNATAKA
590010
India 
Phone  07899245025  
Fax    
Email  dr.shrutigv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Maheswari Ambi 
Designation  PG Student 
Affiliation  Maratha Mandals Dental College and Research Centre Karnataka 
Address  47 A/2,BAUXITE ROAD,NEAR KSRP GROUND, BELGAVI

Belgaum
KARNATAKA
590010
India 
Phone  07899245025  
Fax    
Email  maheshwariambi9@gmail.com  
 
Source of Monetary or Material Support  
Maratha Mandal college of dental sciences and research centre, Belgavi 
 
Primary Sponsor  
Name  DrMaheshwari Ambi 
Address  MARATHA MANDAL’S NATHAJIRAO G. HALGEKAR INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, BELAGAVI KARNATAKA-590010 
Type of Sponsor  Other [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 
DrMaheswari Ambi  Maratha mandals NGH college of dental sciences Belgavi  DEPT OF PEDODONTICS,47 A/2,BAUXITE ROAD,NEAR KSRP GROUND, BELGAVI
Belgaum
KARNATAKA 		 07899245025

maheshwariambi9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maratha Mandal Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Handheld lentulospiral technique   The creamy mix of endoflas was obtained by mixing one scoop of powder with two drops of liquid. A rubber stop was placed at the predetermined working length. A of size 25, lentulospiral length 21 mm (Dentsply) was held by hand; it was inserted into the canal clockwise to allow the material to reach the apex, and then withdrawn from the canal, while simultaneously continuing the anticlockwise motion. A wet cotton pellet was used to lightly press the material.  
Intervention  Indirect vibration technique  The instrument used for indirect vibration was woodpecker UDS-J ultrasonic scaler G1 tip.The creamy mix of endoflas was obtained by mixing one scoop of powder with two drops of liquid. . A plugger of size 25, length 21 mm (Dentsply) was held by hand; stopper at 1 mm short of working length. and endoflas was carried into the canal and the file was vibrated with ultrasonic vibrating tip for 2-3 seconds. A gentle pressure was applied with small cotton pellet. Using the same plugger, the 2nd increment of endoflas was carried into the canals and the instrument was withdrawn against the wall so that maximum obturating material is retained in the canal. The vibrating tip was placed on the height of maximum contour on the buccal aspect and activated for 2-3 sec. A gentle pressure was applied with small cotton pellet.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  [1] Tooth with a persistent history of pain
[2] Bleeding following coronal pulp removal
[3] Inter-radicular radiolucency being present
[4] Clinically non-vital tooth with pus discharge,
 
 
ExclusionCriteria 
Details  [1] Teeth that are irreversibly damaged /non restorable
[2] Teeth exhibiting external or internal root resorption
[3] Follicular cysts
[4] Pathological lesion extending to the successor tooth germ
[5]Special Children /un co-operative children.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Quality of obturation achieved in primary teeth using the two techniques — assessed by radiographic evaluation (periapical radiograph or RVG).  At baseline, single visit 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the quality of obturation with vibration technique in primary teeth  baseline at single visit 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   27/10/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [maheshwariambi9@gmail.com].

  6. For how long will this data be available start date provided 12-10-2025 and end date provided 11-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

This 6-month clinical study was conducted in the Department of Pediatric Dentistry, Maratha Mandal’s Nathajirao G. Halgekar Institute of Dental Sciences, Belagavi, to evaluate two obturation techniques in primary teeth using Endoflas as the obturating material. Forty-eight children aged 4–8 years were selected based on specific clinical and radiographic inclusion criteria and randomly assigned into two groups (n=24 each). All procedures were performed by a single investigator under standardized protocols

 Group A (control) Hand-held lentulospiral technique.

Group B(Test)  Indirect ultrasonic vibration technique.

The quality of obturation was assessed radiographically using Coll and Sadrian’s modified criteria (underfilling, optimal filling, overfilling) by two blinded examiners.

Conventional lentulospiral methods are technique-sensitive and prone to underfilling, voids, or overfilling due to air entrapment and uncontrolled pressure. The ultrasonic vibration method aimed to improve material compaction and reduce such errors. Radiographic assessment was chosen as a reliable, non-invasive method for evaluating obturation quality in children.

This study highlights the potential of advanced obturation techniques to achieve more consistent and optimal fillings in primary root canals compared to traditional methods.

 
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