FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065848 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing methods to fill primary teeth using digital radiography 
Scientific Title of Study   Comparative assessment of different obturating methods in primary teeth using digital radiography: 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  Dr Mansi Baviskar  
Designation  Professor 
Affiliation  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. 
Address  Department of Pediatric and Preventive Dentistry in the basement, Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai.

Thane
MAHARASHTRA
400706
India 
Phone  9970271280  
Fax    
Email  mansi.baviskar@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Chinmaya Chaudhary 
Designation  Post Graduate student 
Affiliation  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. 
Address  Department of Pediatric and Preventive Dentistry in the basement, Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai.

Thane
MAHARASHTRA
400706
India 
Phone  8888897665  
Fax    
Email  dr.chinmayachaudhary@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chinmaya Chaudhary 
Designation  Post Graduate student 
Affiliation  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai. 
Address  Department of Pediatric and Preventive Dentistry in the basement, Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai.


MAHARASHTRA
400706
India 
Phone  8888897665  
Fax    
Email  dr.chinmayachaudhary@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Deemed to be University, School of Dentistry, sector 7, Nerul East, Navi Mumbai Maharashtra 400706 
 
Primary Sponsor  
Name  Department of Pediatric and Preventive Dentistry 
Address  Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706  
Type of Sponsor  Private medical college 
 
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 MAnsi Baviskar  D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai   Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra.
Thane
MAHARASHTRA 		 9970271280

mansi.baviskar@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai  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  Group 1 - tuberculin syringe with metal tips Group 2 - tuberculin syringe with metal tips plastic tips Group 3 - Lentulospiral Group 4 - Past inject carrier  Four techniques of obturation will be compared for quality of obturation and presence of voids. 
Intervention  Pulpectomy of carious primary molar teeth.   Under isolation with rubber dam access cavity will be prepared in each tooth and the infected necrotic pulp tissue will be removed. Working length will be determined and established 1 mm short of the radiographic apex. Biomechanical preparation of the canals will be done till 35 K-file (21 mm). The canals will be repeatedly irrigated alternatively with 1% sodium hypochlorite solution and saline. After instrumentation is complete, the root canals will be dried using absorbent paper points. Post this, all canals will be obturated with Endoflas using the obturating technique assigned to that individual root canal. Duration of obturation - Until complete exfoliation of the primary tooth or any signs and symptoms of abscess.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.
2. Radiographically teeth with 2/3rd root remaining. 
 
ExclusionCriteria 
Details  1. Teeth with caries extending to the furcation.
2. Root canals with evidence of internal or external resorption
3. Developmental tooth anomalies
4. Children with any systemic disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of Obturation and presence of voids   Quality of Obturation and presence of voids at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Technique with best quality of obturation which is easier for the operator & well accepted for the child.   During obturation of the teeth at baseline. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/04/2024 
Date of Study Completion (India) 15/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

AIM

To compare and assess different obturation  techniques  in primary teeth using digital radiography.

OBJECTIVES

1.     To assess the efficacy of different obturation  techniques  in primary teeth using digital radiography.

2.     To compare the efficacy of different obturation  techniques  in primary teeth using digital radiography.

MATERIALS AND METHODS

Study design â€“ Single Blinded Randomized Clinical trial

Study subjects â€“ Children between the age group of 5-8 years

Sample size â€“ 120 canals

Sample selection: The study sample will include children between the age group of 5-8 years with carious deciduous molar teeth visiting the department of Pediatric and Preventive Dentistry.

Group I – Tuberculin syringe with metal tip

Group II: Tuberculin syringe with plastic tip.

Group III: Lentulo-spiral

Group IV: Past inject carrier

CRITERIA FOR SAMPLE SELECTION –

INCLUSION CRITERIA:

1.    Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.

2.    Radiographically teeth with 2/3rd root remaining.

EXCLUSION CRITERIA:

1.     Teeth with caries extending to the furcation.

2.     Root canals with evidence of internal or external resorption

3.     Developmental tooth anomalies

4.     Children with any systemic disease

PROCEDURE â€“

A total sample of 120 canals of primary molar teeth with 2/3rd of root length will be selected which require pulpectomy and will be randomly allocated using chit system into four different obturating techniques, i.e., Group I: Tuberculin syringe with metal tip, Group II: Tuberculin syringe with plastic tip, Group III: Lentulo-spiral, and Group IV: Past inject carrier. Under isolation with rubber dam access cavity will be prepared in each tooth and the infected necrotic pulp tissue will be removed. Working length will be determined and established 1 mm short of the radiographic apex. Biomechanical preparation of the canals will be done till 35 K-file (21 mm). The canals will be repeatedly irrigated alternatively with 1% sodium hypochlorite solution and saline. After instrumentation is complete, the root canals will be dried using absorbent paper points. Post this, all canals will be obturated with Endoflas using the obturating technique assigned to that individual root canal. The quality of obturation, density and presence or absence of voids will be evaluated using digital radiography.

 
Close