| CTRI Number |
CTRI/2021/05/033614 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of quality of root canal filling and root canal preparation time using three electical root canal instruments in last milk teeth of lower jaw |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF QUALITY OF OBTURATION AND INSTRUMENTATION TIME USING THREE ROTARY FILE SYSTEMS IN PRIMARY MANDIBULAR SECOND MOLARS: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHADIYA N T |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOZHIKODE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
GOVERNMENT DENTAL COLLEGE KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
9847483999 |
| Fax |
|
| Email |
shadiyant6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KANNAN VADAKKEPURAYIL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOZHIKODE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
GOVERNMENT DENTAL COLLEGE KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
9446506755 |
| Fax |
|
| Email |
kannanpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KANNAN VADAKKEPURAYIL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOZHIKODE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
GOVERNMENT DENTAL COLLEGE KOZHIKODE
Kozhikode
KERALA
673008
India |
| Phone |
9446506755 |
| Fax |
|
| Email |
kannanpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT DENTAL COLLEGE KOZHIKODE |
|
|
Primary Sponsor
|
| Name |
DR SHADIYA N T |
| Address |
JUNIOR RESIDENT
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
GOVERNMENT DENTAL COLLEGE KOZHIKODE
KERALA
673008 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shadiya N T |
Government Dental College Kozhikode |
Department of Pedodontics and Preventive Dentistry, GDC KOZHIKODE
Kozhikode
KERALA |
9847483999
shadiyant6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College Kozhikode |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K046||Periapical abscess with sinus, (4) ICD-10 Condition: K047||Periapical abscess without sinus, (5) ICD-10 Condition: K042||Pulp degeneration, (6) ICD-10 Condition: K040||Pulpitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo S file system |
The root canals will be instrumented with Kedo S pediatric rotary files |
| Intervention |
Kedo SG Blue file system |
The root canals will be instrumented with Kedo SG Blue pediatric rotary files |
| Comparator Agent |
MTwo file system |
The root canals will be instrumented using only MTwo file of 0.04 taper and 0.25 tip |
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary mandibular second molars with 3 canals showing signs of irreversible pulpitis and necrotic pulp
2. Primary mandibular second molar with furcation or periapical radiolucency
3. Primary mandibular second molar with full length of root without any resorption
4. Primary mandibular second molar with adequate crown structure to support a rubber dam |
|
| ExclusionCriteria |
| Details |
1.Children with medical complication
2.Primary mandibular second molar which is grossly decayed and cannot be restored
3.Primary mandibular second molar with pathological mobility and tooth close to exfoliation
4.Primary mandibular second molar with external or internal root resorption |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the quality of obturation and instrumentation time of root canal preparation, prepared using MTwo , Kedo S , Kedo SG Blue rotary file systems in primary mandibular second molars based on Coll and Sadrian criteria(underfill ,optimal fill and overfill) |
Before and after root canal preparation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for root canal preparation, prepared using MTwo , Kedo S, Kedo SG Blue rotary file systems in primary mandibular second molars |
Before and after root canal preparation |
|
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Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a double blinded randomized controlled trial to compare and evaluate the obturation quality of root canals prepared using MTwo , Kedo S and Kedo SG Blue file systems in primary mandibular second molars of children aged 4-7 years radiographically that will be conducted in the Department of Pedodontics and Preventive Dentistry ,Government Dental College Kozhikode.The primary outcome measure will be quality of obturation obtained by the three rotary file systems based on the Coll and Sadrian criteria(underfill, optimal fill , overfill) and to compare the time taken by each file system. |