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
|
|
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
|
|
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. |