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CTRI Number  CTRI/2011/06/001776 [Registered on: 02/06/2011] Trial Registered Prospectively
Last Modified On: 05/02/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Root canal treatment in milk teeth using three root canal filling materials: A Double-blinded Randomized Controlled Trial.  
Scientific Title of Study   Pulpectomies in Primary Molars Using Three Root Canal Filling Materials: 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  DrRPramila  
Designation  Dentist[postgraduate] 
Affiliation  Saveetha Dental College 
Address  Dr.R.Pramila postgraduate[pedodontics] Saveetha dental college 162 Poonamallee gigh road Velappanchavadi Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9003597232  
Fax    
Email  dr.pramee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMSMuthu 
Designation  Pediatric Dentist 
Affiliation  Saveetha Dental College 
Address  Professor and Head of the Department Department of Pedodontics and Preventive Dentistry Saveetha dental college 162 Poonamallee gigh road Velappanchavadi Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9444045094  
Fax    
Email  muthumurugan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRPramila 
Designation   
Affiliation   
Address  Department of pedodontics and preventive dentistry Room no 301 3rd floor Saveetha dental college 162 Poonamallee gigh road Velappanchavadi Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9003597232  
Fax    
Email  dr.pramee@gmail.com  
 
Source of Monetary or Material Support  
saveetha dental college saveetha university 162 poonamallee high road velappanchavadi chennai 77 
 
Primary Sponsor  
Name  Dr R Pramila 
Address  Dr R Pramila Postgraduate Department of Pedodontics Saveetha dental college Saveetha University 162 Poonamallee high road Velappanchavadi Chennai 77 
Type of Sponsor  Other [postgraduate student] 
 
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 R Pramila  saveetha dental college  Department of Pedodontics and Preventive Dentistry Room no 301 3rd floor Saveetha dental college 162 poonamallee high road Velappanchavadi chennai 77
Chennai
TAMIL NADU 
9003597232

dr.pramee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1. Non vital teeth 2. Teeth with deep carious lesion and exposures of pulp 3. Patients with the history of spontaneous pain 4. Teeth showing adequate bone support and root length ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulpdent Root Canal Sealer Group  A Zinc oxide eugenol preparation. A single visit pulpectomy procedure. Duration: 1 hour. 
Intervention  RC Fill Group  A combination of Zinc Oeide Eugenol and Iodoform. A single visit pulpectomy procedure. Duration of treatment: 1 hour. 
Comparator Agent  Vitapex Group  A combination of calcium hydroxide and iodoform. A single visit pulpetomy procedure. Duration: 1 hour. It is compared with RC Fill and Pulpdent Root Canal Sealer groups. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Non vital teeth
2. Teeth with mild or moderate mobility [grade I and II]
3. Teeth with deep carious lesion and exposures of pulp
4. Patients with the history of spontaneous pain
5. Teeth showing adequate bone support and root length
6. Teeth with no radiographically discernable internal or pathological external resorption
7. Teeth with inter-radicular and peri-radicular radiolucencies.

 
 
ExclusionCriteria 
Details  Children with any medical history are excluded from the study.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
clinical evaluation: Pain, Redness, Swelling/Abscess, Draining fistula and Mobility.
Radiographic evaluation: Furcation radiolucency, Periapical radiolucency, Internal/External root resorption, Deviated eruption of succedaneous teeth, Excessive filling material and its resorption.
 
Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.

 
 
Secondary Outcome  
Outcome  TimePoints 
No Secondary Outcome measures applicable for this study.  Not applicable 
 
Target Sample Size   Total Sample Size="111"
Sample Size from India="111" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pulpectomy is indicated in teeth that show evidence of chronic inflammation or necrosis in the radicular pulp, with or without periapical or furcation pathology. However, endodontic treatment of primary teeth is more challenging than that of their permanent counterparts; this is because of their anatomical complexities of their root canal systems and their proximity to the developing permanent tooth, coupled with the difficulty in behavior management in children. Presently, the most commonly used materials are: Zinc-Oxide Eugenol, Iodoform based pastes, and calcium hydroxide.  In 1967, it was shown that ZOE set in a dense mass which resisted resorption and was very irritating to the periapical tissues in rats.  In 1979, it was speculated that the resorption rate of ZOE and the root differed, resulting in small areas of ZOE paste possibly being retained and because of its hardness it might deflect the path of eruption of the succedaneous tooth.  It also has limited antibacterial action, and cause necrosis of bone and cementum.  Dominguez et al, reported that combining Iodoform and Calcium Hydroxide, it gave a success rate of 100%.  But the main disadvantage was intra-radicular resorption of the material.  A mixture of Calcium Hydroxide, ZOE, and Iodoform [ENDOFLAS] gave a success rate of 83% with good healing, having the resorption limited to the excess extruded extraradicularly, without washing intra-radicularly and resorptive capabilities and was said to be a good alternative to the traditionally used materials.  There have been only limited human studies on this subject. The present study aims to evaluate the clinical and radiographic efficiency of three root filling materials – ZOE with Iodoform [RC Fill], Calcium hydroxide with Iodoform [VITAPEX], ZOE and Calcium hydroxide with Iodoform [ENDOFLAS], for a period of 3,6 and 12 months.

     

 
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