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CTRI Number  CTRI/2014/11/005197 [Registered on: 12/11/2014] Trial Registered Retrospectively
Last Modified On: 11/11/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of biologically based root canal procedures in periapically involved young immature permanent teeth 
Scientific Title of Study   Comparative evaluation of efficacy of biologically based regenerative endodontic procedures in healing of periapically involved young immature permanent teeth with/without using MTA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHIVANI GUPTA 
Designation  POST GRADUATE STUDENT 
Affiliation  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA 
Address  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
Ambala
HARYANA
0171
India 
Phone  9034814652  
Fax    
Email  shivanigupta088@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHALINI GARG 
Designation  PROFESSOR 
Affiliation  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA 
Address  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
Ambala
HARYANA
0171
India 
Phone  9215668621  
Fax    
Email  shaloosandeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHIVANI GUPTA 
Designation  POST GRADUATE STUDENT 
Affiliation  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA 
Address  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA

HARYANA
0171
India 
Phone  9034814652  
Fax    
Email  shivanigupta088@gmail.com  
 
Source of Monetary or Material Support  
M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA 
 
Primary Sponsor  
Name  MM COLLEGE OF DENTAL SCIENCES AND RESEARCH 
Address  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA 
Type of Sponsor  Research institution and hospital 
 
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 
SHIVANI GUPTA  M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY M.M COLLEGE OF DENTAL SCIENCES AND RESEARCH MULLANA AMBALA
Ambala
HARYANA 		 9034814652

shivanigupta088@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE OF MAHARISHI MARKENDESHWAR UNIVERSITY MULLANA AMBALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PERIAPICALLY INVOLVED YOUNG IMMATURE PERMANENT TEETH 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  REVASCULARIZATION WITH MTA, APEXIFICATION WITH MTA  BIOLOGICALLY BASED ENDODONTIC PROCEDURES ARE PERFORMED USING MINERAL TRIOXIDE AGGREGATE(MTA) 
Comparator Agent  REVASCULARIZATION WITHOUT USING MTA  BIOLOGICALLY BASED ENDODONTIC PROCEDURE PERFORMED WITHOUT USING MINERAL TRIOXIDE AGGREGATE(MTA) 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Permanent teeth with immature apices
ï‚· Children free from any systemic illness & good
general health
ï‚· Incompletely formed root.
ï‚· Adequate bone
ï‚· Clinically exposed teeth showing delayed response
to pulp sensibility test(cold test with dry ice
snow ,heat test and electric pulp tester. 
 
ExclusionCriteria 
Details  Teeth undergoing root resorption
ï‚· Teeth with mature root apices
ï‚· Children with any major illness or any history of
systemic disease
ï‚· Teeth with periapical radiolucency of grade5(Acc
to PAI Score) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Clinical parameters
Pain (Present/Absent)
Location(localised/diffuse/radiating)
Intensity(mild/moiderate/severe)
Quality(sharp/throbbing/dull/boring)
Duration
Frequency
Sinus (Present/Absent)
Tenderness to Percussion (Present/Absent)
Swelling (Present/Absent)
Mobility (Grade – 0, 1, 2, 3)
Intact restoration (yes/no)

Radiographic parameters
Nolla stage /Demirjain stage
Root lengthening
Thickening of walls
Lamina dura continuity
Periapical Healing(PAI Score).
 		 3months,6months,9months,12months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical parameters
Pain (Present/Absent)
Location(localised/diffuse/radiating)
Intensity(mild/moiderate/severe)
Quality(sharp/throbbing/dull/boring)
Duration
Frequency
Sinus (Present/Absent)
Tenderness to Percussion (Present/Absent)
Swelling (Present/Absent)
Mobility (Grade – 0, 1, 2, 3)
Intact restoration (yes/no)

Radiographic parameters
Nolla stage /Demirjain stage
Root lengthening
Thickening of walls
Lamina dura continuity
Periapical Healing(PAI Score).
 		 AT 3 MONTHS, 6 MONTHS, 9 MONTHS, 12 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/02/2013 
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)   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    A clinical management of young immature clinically non vital permanent teeth will be done using revascularization and apexification technique with/without using Mineral Trioxide Aggregate. Total of 30 young permanent immature teeth will be taken in healthy children between the age of 7-14yrs. The primary outcome measures will be clinical and radiographic success at 3,6,9,12 months. 
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