| CTRI Number |
CTRI/2024/02/063133 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reduction in Pain after Topical Application of Lignocaine gel, Flavored lignocaine gel and Honey in Children Aged 6–12 years requiring Local anaesthesia Infiltration for Dental Treatment. |
|
Scientific Title of Study
|
To assess reduction in Pain Perception after topical application of Lignocaine gel, Flavored lignocaine gel and Honey in children aged 6–12 years requiring local anaesthesia infiltration for dental treatment: 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 |
Krishna Kajave |
| Designation |
Post graduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9663751557 |
| Fax |
|
| Email |
Krishnakajave1923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niraj Gokhale |
| Designation |
Professor |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Kajave |
| Designation |
Post-graduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9663751557 |
| Fax |
|
| Email |
Krishnakajave1923@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE VK Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Krishna Kajave |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Krishna Kajave |
KAHERs KLE VK Institute of Dental Sciences, Department of Pediatric and Preventive Dentistry. |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences.
Belgaum
KARNATAKA |
9663751557
Krishnakajave1923@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTE, KLE VK Institute of Dental Sciences, Belagavi, Karnataka |
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 |
Flavoured lignocaine gel |
Reduction in pain perception after topical application of 5% flavoured lignacaine gel at the injection site for 2-3 minutes using sterile cotton tip. |
| Comparator Agent |
Honey gel |
Reduction in pain perception after topical application of honey at the site of injection for 2-3 minutes using sterile cotton tip. |
| Comparator Agent |
Lignocaine gel |
Reduction in pain perception after topical application of 2% lignocaine gel at the site of injection for 2-3 minutes using sterile cotton tip. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between 6-12 years of age.
Children visiting dental clinic for the first time.
Children who require administration of local anaesthesia infiltration (maxillary) for the dental treatment.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain perception |
Reduction in pain perception immediately after injecting local anaesthesia infiltration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
20/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/06/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 - NO
|
|
Brief Summary
|
The aim of the study will be to evaluate and compare the effectiveness of topical application of lignocaine gel, flavored lignocaine gel and honey at injection site for reducing pain in children aged 6–12 years requiring maxillary local anaesthesia infiltration for dental treatment. Children who fulfil the inclusion and exclusion criteria will be made to sit comfortably on the dental chair and the procedure will be explained to the parent as well as the children. A case history will be recorded so as to have systematic and methodological recording of all the observations and information. Pulse rate will be recorded prior to the administration of local anaesthesia. The site of injection will be wiped with a clean sterile gauze. Topical anaesthetic will be then applied to the site using a sterile cotton tip applicator for 2 minutes. A preloaded syringe of 2% lignocaine with 1:80,000 adrenaline will be used to deliver local anaesthetic at the injection site. Pulse rate will be recorded after the administration of local anaesthetic. Pain perception will be recorded subjectively by the Wong bakers faces pain rating scale and will be done objectively by the sound, eye, body movement scale.
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