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CTRI Number  CTRI/2018/05/014310 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 23/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check the efficacy of calcium hydroxide, triple antibiotic paste and metapex in treatment of infected immature teeth  
Scientific Title of Study   Comparative evaluation of efficacy of calcium hydroxide, triple antibiotic paste and metapex in apexification 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayali Mali 
Designation  Postgraduate student 
Affiliation  Nair hospital dental college 
Address  302, third floor, Department of Pediatric and Preventive Dentitry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
302, third floor, Department of Pediatric and Preventive Dentistry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
Mumbai
MAHARASHTRA
400008
India 
Phone  9665943624  
Fax    
Email  sayali.mali1227@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Adesk Kakade 
Designation  Professor and Head 
Affiliation  Nair hospital dental college 
Address  302, third floor, Department of Pediatric and Preventive Dentistry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
302, third floor, Department of Pediatric and Preventive Dentistry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
Mumbai
MAHARASHTRA
400008
India 
Phone  9821289144  
Fax    
Email  adeshkakade@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Adesk Kakade 
Designation  Professor and Head 
Affiliation  Nair hospital dental college 
Address  302, third floor, Department of Pediatric and Preventive Dentistry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
302, third floor, Department of Pediatric and Preventive Dentistry, Nair hospital dental college, Dr. A.L. Nair road, Mumbai Central (E).
Mumbai
MAHARASHTRA
400008
India 
Phone  9821289144  
Fax    
Email  adeshkakade@rediffmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental college, Dr. A.L.Nair road, opposite Maratha mandir, Mumbai Central (East) 400008 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
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 
SAYALI MALI  Nair hospital dental college  Nair hospital dental college Dr. A. L. Nair road, Mumbai central.
Mumbai
MAHARASHTRA 
9665943624

sayali.mali1227@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC NHDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  fractured non vital maxillary anterior teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. SAYALI MALI 2. ADESH KAKADE  1. PRINCIPAL INVESTIGATOR 2. CO-INVESTIGATOR 
Comparator Agent  SAYALI MALI  PRINCIPAL INVESTIGATOR 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  CHILDREN WITH TRAUMATIZED NON VITAL PERMANENT MAXILLARY INCISORS,DELAYED RESPONSE TO PULP VITALITY TESTS, ADEQUATE BONE SUPPORT, NO MOBILITY, GOOD RESTORABILITY 
 
ExclusionCriteria 
Details  TEETH HAVING PATHOLOGIC RESORPTION,HORIZONTAL OR VERTICAL ROOT FRACTURES, PERIAPICAL INFECTION MORE THAN 3 mm IN SIZE, CHILDREN WITH COMMUNICABLE OR SYSTEMIC DISEASES, MENTAL RETARDATION, HISTORY OF PREVIOUS TREATMENT, ANKYLOSIS 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
UNEVENTFUL GROWTH OF ROOT APEX AND CLOSURE OF APEX  1,3 and 6 months postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/12/2015 
Date of Study Completion (India) 10/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In this study, materials used other than calcium hydroxide are Metapex and Triple antibiotic paste. Metapex is a combination of calcium hydroxide and iodoform in which advantages of Ca(OH)2 and antiseptic activity of Iodoform is clubbed. Whereas,Triple antibiotic paste (mixture of metronidazole, doxycycline and minocycline in same amount)  allows complete disinfection of canals thus helps in keeping sterile canals and promote apexification.

            Purpose of this study is to compare efficacy as well as time taken for formation of apical barrier using combination of calcium hydroxide and iodoform (metapex) in apexification of traumatized or carious necrotic immature permanent teeth. Newer techniques have recently evolved as treatment options for immature necrotic teeth revascularization and tissue engineering. More research is required in this field.

 
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