| CTRI Number |
CTRI/2024/06/069107 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare whether laser and ice popsicle are as effective as local anesthesia gel in reducing pain while administering injection |
|
Scientific Title of Study
|
To compare the effectiveness of laser bio stimulation (LBS), ice popsicle and anesthetic gel in reduction of local anesthesia injection pain in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Gosavi |
| Designation |
PG student |
| Affiliation |
RUHS College of Dental Sciences,Jaipur |
| Address |
Dept of Pediatric and preventive dentistry room number 7 RUHS College of dental sciences shastri nagar opp space cinema Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
|
| Fax |
|
| Email |
HJGOSAVI@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Tandon |
| Designation |
Sr Professor |
| Affiliation |
RUHS college of dental sciences |
| Address |
Dept of Pediatric and preventive dentistry, room number 7 RUHS College of dental sciences shastri nagar opp space cinema Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
9829065148 |
| Fax |
|
| Email |
drsandeeptandon@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Tandon |
| Designation |
Sr Professor |
| Affiliation |
RUHS college of dental sciences |
| Address |
Dept of Pediatric and preventive dentistry, room number 7 RUHS College of dental sciences shastri nagar opp space cinema Jaipur
RAJASTHAN
302016
India |
| Phone |
9829065148 |
| Fax |
|
| Email |
drsandeeptandon@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| RUHS college of dental sciences,shastri nagar, opp cinema,Jaipur, 302016 |
|
|
Primary Sponsor
|
| Name |
DrHarshita Gosavi |
| Address |
Dept of Pediatric and preventive dentistry room number 7 RUHS College of dental sciences shastri nagar opp space cinema Jaipur 302016 India |
| 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 Harshita Gosavi |
RUHS College of Dental Sciences,Jaipur |
Dept of Pediatric and preventive dentistry room number 7 RUHS College of dental sciences shastri nagar opp space cinema Jaipur
Jaipur
RAJASTHAN |
08652262078
HJGOSAVI@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS College of Dental Sciences,Jaipur |
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 |
Ice Popsicle |
Prior to palatal infiltration, Ice popsicle (orange flavored) is applied at the injection site for 1 min.
|
| Comparator Agent |
Laser Biostimulation |
Prior to palatal infiltration, Diode laser: 0.3 W power at a wavelength of 980 nm and probe tip kept 2 mm away from the surface in pulsed mode for 1 minute.
|
| Intervention |
Local anesthetic gel |
Prior to palatal infiltration, 2% Local anesthetic gel is applied for 1 min |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 9-12 years of either gender requiring palatal infiltration
2. Cooperative children with Frankl Behavior rating 3 or 4 |
|
| ExclusionCriteria |
| Details |
1. Uncooperative children ( Frankl behaviour rating 1 or 2)
2. Any history of abscess or redness at injection site
3. Patients 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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Ice popsicle is as effective as local anesthetic gel to reduce pain and discomfort prior to injection
2. Laser biostimulation is as effective as local anesthetic gel to reduce pain and discomfort prior to injection. |
Immediately post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ice popsicle and Laser Biostimulation can be used to reduce pain and discomfort and can be an alternative to topical anesethetic |
Post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="0"
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
|
Title: Effectiveness of laser biostimulation , ice popsicle and anesthetic gel in reduction of local anesthesia injection pain in children Aim: To compare the effectiveness of laser bio stimulation (LBS), ice popsicle, and LA gel in reducing pain during administration of LA injection in children aged 9-12 years. Objectives: 1. To evaluate efficacy of ice popsicle in reducing pain during administration of LA injection 2. To evaluate efficacy of laser biostimulation in reducing pain during administration of LA injection 3. To compare the effectiveness of laser bio stimulation (LBS), combination of cryotherapy and sugar, and LA gel in reducing pain during administration of LA injection Material and Methods: This is a randomized controlled double-blind study that will be carried out on children aged 9-12 years reporting to outpatient Department of Pediatric and Preventive Dentistry, RUHS College of Dental Sciences, Jaipur after approval from the ethical committee and prior consent from the parents. Patients will be randomly divided into 3 groups: Group A: LA gel application Group B: Ice popsicle application Group C: Laser bio stimulation The assessments of pain response were carried out during the administration of local anesthesia using Wong-Baker Faces Pain Rating Scale and Sound Eyes Motor scale (SEM), respectively. Inclusion criteria: Children aged 9-12 years of either gender requiring palatal anesthesia Cooperative children with Frankl behaviour rating scale- III or IV Exclusion criteria: Uncooperative children (Frankl behavior I and II) Any history of abscess, redness at the injection site. Patients not willing to participate in the study
Groups: Group A: 2% Local anesthetic gel Group B: Ice popsicle Group C; Laser Photobiostimulation |