| CTRI Number |
CTRI/2024/09/074106 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain and anxiety in children using metal syringe versus computerized anesthesia |
|
Scientific Title of Study
|
Comparative evaluation of pain perception and anxiety level during the administration of inferior alveolar nerve block using Computer Controlled Local Anesthetic Delivery System CCLADS and conventional local anesthetic delivery system in children 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 Liza Swain |
| Designation |
PG trainee |
| Affiliation |
SCB dental college and hospital |
| Address |
Department of pediatric and preventive dentistry, SCB dental college and hospital, Mangalabag, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
7504839493 |
| Fax |
|
| Email |
lizadhirendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prayas Ray |
| Designation |
Associate professor |
| Affiliation |
SCB dental college and hospital |
| Address |
Department of pediatric and preventive dentistry, SCB dental college and hospital, Mangalabag, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9861421455 |
| Fax |
|
| Email |
askdrprayas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Liza Swain |
| Designation |
PG trainee |
| Affiliation |
SCB dental college and hospital |
| Address |
Department of pediatric and preventive dentistry, SCB dental college and hospital, Mangalabag, Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
7504839493 |
| Fax |
|
| Email |
lizadhirendra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Liza Swain
Ladies hostel, SCB dental college and hospital, Mangalabag, Cuttack, Odisha, 753007
|
|
|
Primary Sponsor
|
| Name |
Dr Liza Swain |
| Address |
Ladies hostel, SCB dental college and hospital, Mangalabag, Cuttack, Odisha, 753007 |
| 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 Liza Swain |
SCB dental college and hospital |
Department of pediatric and preventive dentistry, SCB dental college and hospital, Mangalabag, Cuttack
Cuttack
ORISSA |
7504839493
lizadhirendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SCB dental college and hospital, cuttack, Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of inferior alveolar nerve block using computer controlled local anesthetic delivery system |
Evaluation of pain perception and anxiety level during administration of inferior alveolar nerve block which takes nearly 3 minutes on average using computer controlled local anesthetic delivery system |
| Comparator Agent |
Administration of inferior alveolar nerve block using conventional local anesthetic delivery system |
Evaluation of pain perception and anxiety level during administration of inferior alveolar nerve block using conventional local anesthetic delivery system |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a. Children requiring inferior alveolar nerve block injections during dental procedures.
b. Children displaying Frankl behaviour ratings 3 and 4.
c. Children who have never been administered with inferior alveolar nerve block. |
|
| ExclusionCriteria |
| Details |
a. Children with learning and audio-visual impairment.
b. Children with any systemic diseases.
c. Children with a pacemaker.
d. Children who are allergic to local anesthetic agents.
e. Children whose parents are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anxiety level (before and after administration of nerve block).
2. Pain perception immediately after administration of nerve block. |
1. Before administration of nerve block.
2. After administration of nerve block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Heart rate
2. Patient comfort level |
1. Before administration of nerve block.
2. After administration of nerve block.
3. During administration of nerve block |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
30/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study will be conducted at SCB Dental College and Hospital, Cuttack, Odisha, India to compare and evaluate pain perception and anxiety level associated with administration of Inferior Alveolar Nerve Block (IANB) using Computer Controlled Local Anesthetic Delivery System (CCLADS) and Conventional Local Anesthetic Delivery System in children. After thorough clinical examinations and relevant investigations, indicated dental procedure will be performed on children in which Inferior Alveolar Nerve Block (IANB) will be administered by either using conventional syringe or SlowJec, a Computer Controlled Local Anesthetic Delivery System (CCLADS). The results obtained will be statistically evaluated in further course of time. |