| CTRI Number |
CTRI/2024/06/068314 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of two different types of irrigation needles in milk teeth. |
|
Scientific Title of Study
|
Evaluating the disinfection effectiveness of two different irrigation needles in primary teeth – A Randomized Controlled Trial |
| 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 Patnana Arun Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room No 115 First floor, Dental OPD
All India Institute of Medical Sciences, Khanderi Para Pipaliya
Rajkot
GUJARAT
360006
India |
| Phone |
9966117228 |
| Fax |
|
| Email |
arun0550@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Patnana Arun Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room No 115 First floor, Dental OPD
All India Institute of Medical Sciences, Khanderi Para Pipaliya
GUJARAT
360006
India |
| Phone |
9966117228 |
| Fax |
|
| Email |
arun0550@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patnana Arun Kumar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room No 115 First floor, Dental OPD
All India Institute of Medical Sciences, Khanderi Para Pipaliya
GUJARAT
360006
India |
| Phone |
9966117228 |
| Fax |
|
| Email |
arun0550@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rajkot |
| Address |
All India Institute Of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 |
| Type of Sponsor |
Government 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 Patnana Arun Kumar |
AIIMS Rajkot |
Room No 115, First Floor, OPD, All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT |
9966117228
arun0550@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Irrigation with open ended needles |
During chemo-mechanical preparation, irrigating agent will be delivered using open ended needles.
The frequency of delivering irrigation with side vented needle is once and the duration of irrigation is one minute.
The irrigation needle will be kept 2 mm short of working length during the delivery of irrigating solution. |
| Intervention |
Irrigation with side vented needles |
During the chemo-mechanical preparation, irrigating agent will be delivered using side vented needles.
The frequency of delivering irrigation with side vented needle is once and the duration of irrigation is one minute.
The irrigation needle will be kept 2 mm short of working length during the delivery of irrigating solution. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children belong to positive or definitely positive classes of the Frankel behavior rating scale.
Children in the age group of 6 – 9 years.
Children with necrotic primary molars with adequate crown structure for post-endodontic restoration.
Children with decayed primary molars with sinus opening
Children with decayed primary molars with furcation radiolucency
Children with decayed primary molars with minimal or no resorption.
|
|
| ExclusionCriteria |
| Details |
Specially challenged children
Children with Negative/Definitely Negative classes of the Frankel behavior rating scale.
Children under analgesics or antibiotics 12 hours before the treatment schedule |
|
|
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 |
| Reduction in the bacterial count |
1st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain |
6 hours, 24 hours, and 7 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Children in the age group of 6-9 years with necrotic primary molars that are indicated for pulpectomy will be included in the trial. The inclusion of participants will be done randomly and every effort will be made to reduce the operator and selection bias while conducting the trial. After getting the informed consent from the parents of the participants, pulpectomy will be initiated under proper isolation of the operating field. Irrigation with an antibacterial solution will be done using either open-ended or side-vented needles as per the randomization code. Bacterial samples will be collected from the root canals before and after irrigation. The collected samples will be transferred for evaluation of bacterial reduction. |