| CTRI Number |
CTRI/2024/09/073244 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the efficacy of two different manual and automated instruments used for treatment of root canals in milk teeth of children |
|
Scientific Title of Study
|
A clinical comparision of two pediatric rotary file systems with manual k files in primary molars |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramba Pavitra |
| Designation |
I MDS |
| Affiliation |
Vishnu dental college |
| Address |
Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
09398011575 |
| Fax |
|
| Email |
pavitrarambha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRavigna |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
09160305555 |
| Fax |
|
| Email |
ravigna.p@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRavigna |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
09160305555 |
| Fax |
|
| Email |
ravigna.p@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Ramba Pavitra |
| Address |
Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Vishnupur Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
| Type of Sponsor |
Other [self] |
|
|
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 Ramba Pavitra |
Vishnu Dental College |
Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Vishnupur Bhimavaram West Godavari
West Godavari
ANDHRA PRADESH |
9398011575
pavitrarambha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biomechanical Preparation of root canals with Kedo- S-Plus rotary files in primary molars |
Biomechanical preparation of root canals will be done for 10 minutes of duration using Kedo-S-Plus rotary files in primary molars |
| Comparator Agent |
Biomechanical Preparation of root canals with Manual K-Files
in primary molars |
Biomechanical Preparation of root canals will be done using Manual K-Files in primary molars for 15 minutes of duration |
| Intervention |
Biomechanical Preparation of Root canals with Pro AF Baby gold rotary files in primary molars |
Biomechanical Preparation of Root canals will be done with Pro AF Baby gold rotary files in primary molars for 10 minutes of duration |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children willing to participate in the study
2. Healthy Children between 5-8 years of age.
3. Frankels behavior rating scale positive.
4. Teeth indicated for single visit pulpectomy. |
|
| ExclusionCriteria |
| Details |
1. Children with any systemic conditions, mental and physical disabilities
2. Pathological root resorption
3. Excessive mobility
4. Presence of interradicular radiolucency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain assessment |
post operative pain assessment after 24hrs using wong-baker faces pain rating scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| radiographic assessment of quality of obturation |
post operative evaluation of
pulpotamized tooth after 6 months clinically and radiographically |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
13/09/2024 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary teeth plays major role in the guiding of the permanent teeth to erupt in correct position in the dental arch.it was crucially important to retain and preserve the primary teeth from bacteria causing dental caries.on the diagnosis of pulpal inflammation where the pulp get necrosed or infected.endodontic treatment should be preferred to remove the infected pulp from the decayed teeth.The success of pulpectomy was strongly reliant on the instrumentation techniques,with less instrumentation time and good quality of obturation. Previously Manual k-files were used to remove the diseased pulp tissue and helps in shaping the canals in primary teeth. When compared to manual k files, rotary files system provides smooth and predefined conical shapes with least amount of risk.Screening of Children aged 5-9 years requiring single visit pulpectomy attending OPD using computer generated sequence groups were divided Group 1 includes Manual k-files , group 2 includes kedo s plus and group 3 includes pro Af Baby gold files A standard protocol will be followed for pulpectomy and radiographic method of working length determination will be done. BMP will be done using manual k files in one group and rotary file system in another two groups and instrumentation time will be recorded in seconds using stop watch, followed by irrigation using 1% sodium hypochlorite. Obturation will be done using zinc oxide eugenol cement. Quality of obturation will be assessed using post operative radiograph based on kedoo classification criteria and finally post operative pain assessment using wong baker faces pain rating scale Obtained data will be subjected to statistical analysis. |