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CTRI Number  CTRI/2019/06/019908 [Registered on: 27/06/2019] Trial Registered Prospectively
Last Modified On: 24/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of Three Different Root Canal Filling Materials for Root Canal Treatment in Children 
Scientific Title of Study   Clinical and Radiographic Outcomes of Three Root Canal Obturating Materials for Pulpectomy in Primary Mandibular Molars: A Double Blinded Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragyna Priyadarshini 
Designation  Post graduate student 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Paediatric and Preventive Dentistry Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8457872002  
Fax    
Email  pragyna.mitan2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepa Gurunathan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Paediatric and Preventive Dentistry Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9994619386  
Fax    
Email  drgdeepa@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Deepa Gurunathan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Paediatric and Preventive Dentistry Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9994619386  
Fax    
Email  drgdeepa@yahoo.co.in  
 
Source of Monetary or Material Support  
Self funded (Dr. Pragyna Priyadarshini Postgraduate Department of Paediatric and Preventive Dentistry Saveetha Dental College and Hospitals  
 
Primary Sponsor  
Name  Pragyna Priyadarshini 
Address  Department of Paediatric and Preventive Dentistry Saveetha Dental College and Hospitals 162 Poonamallee High road Chennai 600077 
Type of Sponsor  Other [Self funded] 
 
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 
Pragyna Priyadarshini  Saveetha Dental College and Hospitals  Department of Paediatric and Preventive Dentistry 5th Floor, Clinic number 28 Division of Dentistry
Chennai
TAMIL NADU 
8457872002

pragyna.mitan2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College and Hospitals Scientific Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 Endoflas-FS  Endoflas-FS is a latest obturating material used for pulpectomy in children which consists basically of calcium hydroxide zinc oxide iodoform and liquid eugenol Sample size 28 participants 
Intervention  Group 2 Endoflas powder with Curcumin gel  Endoflas powder is added to commercially available Curcumin gel and liquid eugenol is eliminated Sample size 28 participants 
Comparator Agent  Group 3 Pulpdent Root Canal Sealer Zinc oxide eugenol  Pulpdent Root Canal Sealer consists of zinc oxide powder and liquid eugenol Sample size 28 participants 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Carious/deeply carious teeth with intra/extra-oral swelling/draining sinus tract
Abnormal mobility
Spontaneous pain with tender on percussion
Continuous bleeding on amputation of coronal pulp
Furcation/periapical radiolucency
Internal root resorption involving only cervical 1/3rd of root
External root resorption involving 1/3rd or less than 1/3rd of root length
 
 
ExclusionCriteria 
Details  Children with systemic pathosis/special care needs
Untoward reaction to LA or to ingredients of test materials
Teeth not restorable/perforated pulpal floor
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
CLINICAL OUTCOMES :
Pain
Tenderness to percussion
Swelling/Abscess
Mobility
Draining fistula
RADIOGRAPHIC OUTCOMES :
Furcation/periapical radiolucency
Internal/External root resorption
Continuity of lamina dura
Deviation in path of eruption of succeedaneous tooth
Intra-radicular resorption
Resorption of extruded material
 
1 week
1 month
3 months
6 months
9 months
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   08/07/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   R. Pramila, M. S. Muthu, G. Deepa, J. M. Farzan, S. J. L. Rodrigues. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Inter Endod J, 49, 413-421, 2016. Mortazavi M, Mesbahi M (2004) Comparison of zinc oxideand eugenol, and Vitapex for root canal treatment ofnecrotic primary teeth. International Journal of PaediatricDentistry 14, 417–24. Rewal N, Thakur A, Sachdev V, Mahajan N. Comparison ofendoflas and zinc oxide eugenol as root canal fillingmaterials in primary dentition. J Indian Soc Pedod Pre Dent2014;32(4):317e21.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The primary objective of pulpal treatment is to preserve the integrity and health of the oral tissues. Endodontics in primary teeth is even more challenging because of the anatomic complexities, dynamic alteration at the root apex and close proximity to the succedaneous tooth bud. In this context root canal filling materials assume added importance, which must be resorbable, anti-bacterial and biocompatible in nature. Zinc oxide eugenol (ZOE) is the most widely used obturating material in primary teeth despite its few drawbacks such as delayed resorption when extruded beyond the apex, deflection in position of underlying successor tooth and its toxicity in periradicular tissues. Thus to overcome such drawbacks, various obturating materials and herbal derivatives have been introduced for pulpal treatment in children. 

Turmeric (Curcumin Longa) is a medicinal herb and has been tested clinically for its antioxidant, antiinflammatory and antimicrobial properties which can be effectively used as an obturating material in primary teeth. The rationale behind the use of Curcumin gel with Endoflas powder is to overcome the disadvantages of Endoflas-eugenol mix.

Thus the present study is undertaken to evaluate the clinical and radiographic outcomes of Endoflas, Endoflas powder with Curcumin gel and Pulpdent root canal sealer (ZOE) as obturating materials in primary mandibular molars. 

 
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