| CTRI Number |
CTRI/2024/02/063023 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of number of root canal openings and ease of detection using three different methods in primary molars |
|
Scientific Title of Study
|
To compare the Detection Rate And Ease Of Locating Root Canal Orifice in Primary Molars Using Surgical Loupes, Fluorescein Sodium Dye And Methylene Blue Dye: An In-Vivo Study |
| 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 Vaibhavi Vijay Pharne |
| Designation |
PG student |
| Affiliation |
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
8329697730 |
| Fax |
|
| Email |
vaibhavipharne@yahoo.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aruna Vishwakarma |
| Designation |
Reader |
| Affiliation |
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
7875268077 |
| Fax |
|
| Email |
draruna_vk@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vaibhavi Pharne |
| Designation |
PG student |
| Affiliation |
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College |
| Address |
Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
8329697730 |
| Fax |
|
| Email |
vaibhavipharne@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhavi Pharne |
| Address |
Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule |
| 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 Vaibhavi Pharne |
Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College |
Department of Pedodontics Room no 5 Second floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA |
8329697730
vaibhavipharne@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z001||Encounter for newborn, infant andchild health examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canal detector Methylene blue |
2-3 drops(0.2 ml) after access opening to locate canals |
| Intervention |
Fluoro Touch Sterile strips |
2-3 drops (0.2 ml) after access opening to locate canals |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients with caries in primary molars involving pulp
Primary molars with atleast two third of root present
Patients with no systemic disease
|
|
| ExclusionCriteria |
| Details |
Patient with any systemic disease
Patient with more than two third root resorption in primary molars
Non restorable primary molars
Uncooperative patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the detection rate and ease of detection of root canal orifices of primary
molar using surgical loupes, canal detector dye (methylene blue) and fluorescein sodium.
|
At the time of start of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate detection rate and ease of detection of root canal orifices of primary molar using surgical loupes
To evaluate detection rate and ease of detection of root canal orifices of primary molar using canal detector dye (methylene blue)
To evaluate detection rate and ease of detection of root canal orifices of primary molar using fluorescein sodium.
|
At the time of start of treatment |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2024 |
| Date of Study Completion (India) |
04/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/06/2024 |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vaibhavipharne@yahoo.in].
- For how long will this data be available start date provided 29-05-2024 and end date provided 30-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Introduction- The major goal of root canal treatment is the thorough mechanical and chemical debridement of all root canals and their complete obturation with an inert filling material and a coronal filling preventing ingress of microorganisms. One of the main reasons for the failure of root canal therapy is the lack of sufficient knowledge concerning the anatomy of teeth, both internal and external. Presence of accessory canals and rare anatomical configuration makes canal orifice location an important step in pulpectomy and emphasizes the need for the operator to be aware of and look out for such variations and use adequate diagnostic methodologies prior to and during therapy to detect such variations. The presence of additional canals makes it difficult to visualize additional canals like Mesio-buccal 2(MB2) and Mid mesial (MM) canal may serve as a major hindrance towards a successful outcome. Hence, this study is planned to compare the detection rate and ease of locating root canal orifices of primary molar using surgical loupes, fluorescein sodium dye and methylene blue dye. Methodology- This is an in-vivo experimental trial to be carried out in department of pedodontics. Each calibrated operator will administer local anaesthesia using 2% Lignocaine with adrenaline for the procedure. Caries excavation and access opening will be achieved using round bur. The coronal pulp tissue will be amputated using a sharp sterile discoid type spoon excavator. The Sodium Fluorescein will be prepared using Sodium Fluorescein strips. It will be dissolved in 2ml of normal saline and 2ml solution in a syringe chamber will be flooded with the dye and allow in the pulp chamber for 20 seconds. The excess dye will be evacuated with a suction apparatus. Blue curing light from photopolymerization unit illuminate the chamber. The root canal orifice will show a bright green fluorescence. For the use of methylene blue dye- dentine will be removed where the root canal orifices are expected and 1-3 drops of dye will be inserted to the bottom of pulp cavity. After 5-10 seconds. Next the pulp cavity will be rinsed and dried. Points intensive dyed in blue will indicate the root canal orifices. The operators will be asked to visualize the orifice of the canals. The operator 1 will locate the canals with surgical loupes and note the number of orifices followed by Operator 2 who will locate the canals using Sodium Fluorescein dye (Flurostripsterileâ„¢ sodium ophthalmic strip) or methylene blue dye and note the number of orifices. The operators will also be asked to rate the ease of locating the no canal orifices using the different aids on a five-point Likert rating scale. |