| CTRI Number |
CTRI/2024/07/070688 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
X ray comparision of three different rootcanal treatment methods. |
|
Scientific Title of Study
|
Radiographic evalution of three different rotary file systems on primary molars obturation A randomised clinical triall |
| 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 Lavudu Bharathi |
| Designation |
Post graduate student |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCE |
| Address |
Room no7
Department of Pediatric and Preventive Dentistry
Anil Neerukonda Institute of Dental Sciences
Sangivalsa Bhemunipatnam
Vishakapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
7416952546 |
| Fax |
|
| Email |
bharathilavudu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr k chaitanya ram |
| Designation |
Professor and head of the Department |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCE |
| Address |
Room no7
Department of Pediatric and Preventive Dentistry
Anil Neerukonda Institute of Dental Sciences
Sangivalsa Bhemunipatnam
Vishakapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
9493120291 |
| Fax |
|
| Email |
fauchard2612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lavudu Bharathi |
| Designation |
Post graduate student |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCE |
| Address |
Room no7
Department of Pediatric and Preventive Dentistry
Anil Neerukonda Institute of Dental Sciences
Sangivalsa Bhemunipatnam
Vishakapatnam
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
7416952546 |
| Fax |
|
| Email |
bharathilavudu123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Science |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Science |
| Address |
Room no7
Department of Pediatric and Preventive Dentistry
Anil Neerukonda Institute of Dental Sciences
Sangivalsa Bhemunipatnam
Vishakapatnam
|
| Type of Sponsor |
Private medical college |
|
|
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 Lavudu Bharathi |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCE |
Room no7
Department of Pediatric and Preventive Dentistry
Sangivalsa Bhemunipatnam
Vishakapatnam
Visakhapatnam
ANDHRA PRADESH |
7416952546
bharathilavudu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heroshapers Rotary File System |
second generation that design looks like H file with more flexibility |
| Comparator Agent |
Kedonano rotary files |
Ni-Ti rotary files with variable taper designs provides flexibility and efficiency |
| Intervention |
Neoendopedoflex Rotary files |
Neoendopedoflex Rotary files with efficient cutting effiency and flexibility |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
The child should be in good health with no history of major systemic illness or allergies.
Primary molars with deep dental caries
History of spontaneous pain
Uncontrolled bleeding during pulpotomy procedure
Teeth with two third of the root length intact. |
|
| ExclusionCriteria |
| Details |
Children with special health care needs and underlying systemic diseases
Excessive tooth mobility.
Presence of external or internal root resorption.
Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic assessment for checking quality of obturation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic assessment of No. of Voids after obturation |
Baseline |
| Radiographic assessment of Level of fill |
Baseline |
|
|
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 4 |
|
Date of First Enrollment (India)
|
21/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
| 60 Children aged 6 to 9 years old who require pulp therapy and willing for treatment will be given an informed consent. After obtaining an informed consent children will be randomly divided into three groups and treated with three different rotary files. After cleaning and shaping done with rotary files, obturation is done and obturation quality will be assessed radiographically. All the obtained data will be tabulated and sent for statistical analysis. | |