CTRI Number |
CTRI/2018/09/015573 [Registered on: 04/09/2018] Trial Registered Prospectively |
Last Modified On: |
30/08/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Root canal preparation in primary teeth |
Scientific Title of Study
|
Comparison of hand, reciprocating and rotary instrumentation technique in primary teeth -A double blinded randomized control trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ganesh Jeevanandan |
Designation |
Reader |
Affiliation |
Saveetha Dental College |
Address |
No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,
Chennai TAMIL NADU 600077 India |
Phone |
09884293869 |
Fax |
|
Email |
helloganz@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ganesh Jeevanandan |
Designation |
Reader |
Affiliation |
Saveetha Dental College |
Address |
No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,
Chennai TAMIL NADU 600077 India |
Phone |
09884293869 |
Fax |
|
Email |
helloganz@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ganesh Jeevanandan |
Designation |
Reader |
Affiliation |
Saveetha Dental College |
Address |
No 28, 5 th floor, 162, Saveetha Dental College, Poonamallee high road, Velappanchavadi,
Chennai TAMIL NADU 600077 India |
Phone |
09884293869 |
Fax |
|
Email |
helloganz@gmail.com |
|
Source of Monetary or Material Support
|
Reeganz Dental Care Pvt Ltd
2182/2 Abirami apartment, Shanthi colony, 12th Main road, Anna nagar , chennai -40 |
|
Primary Sponsor
|
Name |
Reeganz Dental Care Pvt Ltd |
Address |
2182/2 Abiramai apartments 12th main road shanthi colony |
Type of Sponsor |
Private hospital/clinic |
|
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 |
Dr Ganesh Jeevanandan |
Saveetha Dental College |
Department of Pediatric and Preventive Dentistry , Room No 28, 162 Ponnamallee High Road
Velapanchavadi, Thiruvallur TAMIL NADU |
9884293869
helloganz@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethical Commitee, Saveetha Dental College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group 1 |
Hand files |
Intervention |
Group 2 |
Reciprocating files |
Intervention |
Group 3 |
kedo rotary files |
Comparator Agent |
hand file vs rotary files |
comparing a new pediatric specific rotary file ( kedo files ) with hand k-files and reciprocating files |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
patients with
pain in primary molar teeth with any sign and symptoms of irreversible pulpitis due to caries |
|
ExclusionCriteria |
Details |
patients with
primary molars with internal or external resorption
Medically compromised patients |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Quality of obturation with its clinical and radiographic sucess and instrumentation time |
3,6,9,12,15,18,21,24,27,30,33,36 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
instrumentation time, instrument fracture, post operative infection |
baseline, 3, 6,9,12,15,18,21,24,27,30,33,36 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
Date of First Enrollment (India)
|
10/09/2018 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Submit to International Journal to Pediatric Dentistry |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Pulpectomy is the intervention of choice for treating infected pulp tissues in pediatric dental patients. Earlier this treatment was performed with hand instruments. Rotary instruments were introduced to pediatric endodontics in the year 2000. However, morphological challenges posed by the primary root canals demand an improvement in the quality and design of contemporary rotary instruments so as to avoid undesirable complications, viz., canal transportation, ledges, strip perforations, zips, etc. Rotary NiTi files follow the original anatomy of curved canals in primary teeth, and hence minimize the risk of procedural errors. Also, a funnel-shaped canal preparation is obtained, and thus a uniform and more predictable obturation with pastes can be achieved. More importantly, rotary files shorten the preparation time considerably and, therefore, suit the shorter attention spans of children, thus, increasing their cooperation for the endodontic procedure. Recently reciprocating files system has been used in primary teeth for root canal preparation in primary teeth. So, it is necessary to evaluate the best system which results in successful pulpectomy procedure in primary teeth. |