| CTRI Number |
CTRI/2024/11/076932 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of light treatment on local pain reduction during injection with spray for tooth removal in children of age 6 to 12 years
|
|
Scientific Title of Study
|
Comparison of efficacy of Photobiomodulation (PBM) and topical anesthetic spray in reducing the injection pain in children of age 6-12 years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bollepalli Bhavana |
| Designation |
Postgraduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Room No: 5, Block number 3,
Department of Pediatric and Preventive Dentistry, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9581681515 |
| Fax |
|
| Email |
bhavana.bollepalli@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahalya Penmetsa |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room No: 5, Block number 3,
Department of Pediatric and Preventive Dentistry,Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahalya Penmetsa |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room No: 5, Block number 3,
Department of Pediatric and Preventive Dentistry,Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram, 534202, West Godavari, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Bollepalli Bhavana |
| Address |
Room No:5, Block Number 3, Department of Pediatric and Preventive Dentistry Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Pediatric and Preventive Dentistry |
Room No:5, Block Number 3, Department of Pediatric and Preventive Dentistry Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavana Bollepalli |
Vishnu Dental College |
Room No;5, Block Number 3, Department of Pediatric and Preventive Dentistry, Vishnu Dental College, Vishnupur, Bhimavaram 534202, India
West Godavari
ANDHRA PRADESH |
9581681515
bhavana.bollepalli@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VISHNU DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photobiomodulation(810nm Diode laser, 0.6 W power for 3 min) |
For extracting teeth, prior to Local anesthesia administration the area to be anesthetized will be dried, and Photobiomodulation (PBM) using 810nm wavelength diode laser, with 0.6 watt power for a duration of 3 min will be applied on the patient in continuous wave mode. After PBM the local anesthesia administration will be done using 24 gauge needle. During & after administartion of local anesthesia objective as well as subjective pain assessments will be done using Sound Eye Motor Scale, Wong Bakers Pain rating Scales respectively. |
| Intervention |
Photobiomodulation(810nm diode laser, 0.6 watt power, 40 sec) |
For extracting teeth, prior to Local anesthesia administration the area to be anesthetized will be dried, and Photobiomodulation (PBM) using 810nm wavelength diode laser, with 0.6 watt power for a duration of 40 sec will be applied on the patient in continuous wave mode. After PBM the local anesthesia administration will be done using 24 gauge needle. During & after administartion of local anesthesia objective as well as subjective pain assessments will be done using Sound Eye Motor Scale, Wong Bakers Pain rating Scales respectively. |
| Comparator Agent |
Topical Anesthetic spray(Nummit Spray) |
For extracting teeth, prior to Local anesthesia administration the area to be anesthetized will be dried, and topical anesthetic spray(Lidocaine 15%w/w) will be applied for a duration of 1 min on the patient followed by local anesthesia administration using 24 gauge needle. During & after administartion of local anesthesia objective as well as subjective pain assessments will be done using Sound Eye Motor Scale, Wong Bakers Pain rating Scales respectively. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age 6- 12 years requiring local anesthesia administration for extractions.
2.Children without medical history of systemic diseases
3.Patients who have no previous experience of local anesthesia.
• Patients not allergic to local anaesthetics
|
|
| ExclusionCriteria |
| Details |
1.Children who were under any medication (pain killer/ NSAIDS/ Opioids) that might affect anaesthetic assessment.
2.Children who need block for local administration.
3.Children with special health care needs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
subjective pain assessment using wong bakers pain rating scale
objective assessment using Sound eye motor scale |
single visit-baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
27/11/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The study aimed to compare the efficacy of PBM with LA spray in reducing injection pain in children during administration of local anesthesia. Children of age 6-12 years old will be screened attending the outpatient department of Pedodontics and Preventive Dentistry, Vishnu dental college. Details of the study will be explained to the parents and written informed consent will be obtained. Children requiring local anesthesia administration for extractions will be taken and will be randomly allocated into 3 groups . Group – I (Topical anesthetic spray with sham laser), group – 2 (PBM 810nm, 0.6W, 40 sec, CW mode) and group – III (810nm, 0.6W, 3minutes, CW), with a pause of 5 seconds/ 10 seconds for every 30 seconds. Area to be anesthetized will be dried in all the three groups, followed by topical spray application for 1minute in group I, PBM of 810nm, 0.6W, 40 sec, CW will be applied in group II and PBM of 810nm, 0.6W, 3 min, CW with a pause of 5 seconds/ 10 seconds for every 30 seconds will be applied in group III.Administration of local anesthesia infiltration using 24 gauge needle followed by subjective and objective pain assessments with Wong Baker’s Pain rating scale and Sound Eye Motor scale respectively. Data obtained will be subjected to the statistical analysis. |