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CTRI Number  CTRI/2024/05/067126 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to study the effects of laser therapy in the reduction of injection pain in children during extraction of deciduous teeth. 
Scientific Title of Study   Effect of photobiomodulation therapy in reduction of injection pain in children: A randomized control 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 Shilpa N 
Designation  First year post graduate student 
Affiliation  Manipal college of dental sciences, manipal academy of higher education  
Address  Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480259355  
Fax    
Email  shilpa.mcodsmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr N. Sridhar 
Designation  Professor and Head 
Affiliation  Manipal college of dental sciences, manipal academy of higher education  
Address  Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886932642  
Fax    
Email  sridhar.pedo@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa N 
Designation  First year post graduate student 
Affiliation  Manipal college of dental sciences, manipal academy of higher education  
Address  Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480259355  
Fax    
Email  shilpa.mcodsmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of dental sciences Manipal academy of higher education and research Manipal, Udupi Karnataka, India- 576104  
 
Primary Sponsor  
Name  Dr Shilpa N 
Address  Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal academy of higher education Manipal, Udupi Karnataka, India - 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpa N  Manipal college of dental sciences, Manipal  Department of pediatric and preventive dentistry Room number 6 Second floor Manipal college of dental sciences Manipal - 576104
Udupi
KARNATAKA 		 9480259355

shilpa.mcodsmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K046||Periapical abscess with sinus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Photobiomodulation therapy with topical anesthetic gel and local anesthesia  Photobiomodulation therapy will be administered for 60 seconds followed by topical anesthetic gel applied at the same site for 30 seconds following which 1-1.5ml of local anesthesia will be administered at the same site. 
Comparator Agent  Sham laser with topical anesthetic gel and local anesthesia.  Sham laser will be administered for 60 seconds followed by topical anesthetic gel applied at the same site for 30 seconds following which 1-1.5ml of local anesthesia will be administered at the same site. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Pediatric patients in the age group of 6-12 years.
Subjects with positive or definitely positive behaviour (As per FRANKL scale with a score of 3 or 4) during their initial behaviour assessment.
Subjects who require extractions bilaterally.
Intra-oral clinical evaluation shows presence of gross destruction of tooth structure following profound carious involvement with pulpal pathology.
The intra-oral clinical observation presents a tooth exhibiting mobility caused by physiological root resorption.
Clinical cases that require administration of only supra-periosteal injection technique of local anesthesia.
 
 
ExclusionCriteria 
Details  Subjects who have significant medical history and acute or chronic diseases or bleeding disorders.
Subjects who have had previous allergic reactions to local anesthetics and topical anesthetics.
Subjects who have a site of active pathosis in the injection region.
Subjects who have been taking any medication that might affect the anesthetic assessment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Injection pain perception with and without the adjunct use of low-level laser therapy on primary teeth indicated for extraction.  24 weeks, 48 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Comparative effectiveness of low-level laser therapy versus topical anesthetic gel.  72 weeks 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   27/05/2024 
Date of Study Completion (India) 17/10/2025 
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)
Modification(s)  		 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  


After selection of the patients based on the inclusion criteria, the procedure will be explained in detail to the concerned children, guardians/parents and a written informed consent will be obtained and maintained until the research period is complete. 

After obtaining the written informed parental consent, tooth selected based on the inclusion criteria will be divided into two groups using simple randomization by coin-dropping method to determine treatment modality to be performed. The side of intervention will also be specified with the coin-dropping method and allocation concealment will be done.

Each child will be weighed before the treatment and the Maximum Recommended Dose (MRD) of 2% Lignocaine hydrochloride with Adrenaline (1:80000) to be used will be determined. 

Patients will be made to wear the protective glasses before the start of treatment, so they will be blinded to the intervention.  

As the study follows a split mouth design, Photobiomodulation Therapy + topical anesthetic gel followed by supra-periosteal local anesthesia injection will be administered and extraction will be performed only on one of the sides in one visit.

On the other side, sham laser +   topical anesthetic gel followed by supra-periosteal local anesthesia injection will be administered for extraction on a subsequent visit, separated by an interval of 4 to 7 days. 

The treatment to be performed will be initiated after initial desensitization of the child to dental setup in the hospital. 

The behavioural assessment of the child will be done using FRANKL’s Behavioural Assessment Scale (Positive and Definitely Positive patients will be selected- Scores 3 and 4). 

To alleviate the fears of children for the dental procedures, the ‘Tell-Show-Do’ technique will be implemented. 

Prior to application of the Photobiomodulation Therapy, the laser operator will mark the oral mucosa with a two-tone disclosing agent on the outer edge of the silicone piece around the laser fiber, to apply the Low-Level Laser Therapy and anesthesia on the same target area.

A Diode Laser will be used to perform the Photobiomodulation Therapy on one side with a continuous wavelength of 940 nm in a 400 µm fiber. 

In noncontact mode, the fiber of the laser device will be positioned 1 mm away from the application region.

The power of the device will 0.3 W, and the energy intensity will be 69 J/cm2. 

Duration of application of photobiomodulation will be at 60 seconds for Group 1.

Topical Anesthetic Gel will be applied to the site of injection on both sides that are indicated for extraction, using a cotton tip applicator for a period of 30 seconds prior to the supra-periosteal local anesthesia injection. 

1-1.5 mL 2 % Lignocaine hydrochloride with 1:80000 Adrenaline will be injected with a 27-gauge dental needle, and a 2 mL disposable dental syringe. 

The extraction of the indicated tooth will begin, after ascertaining the objective signs of soft tissue anesthesia after the administration of the injection.

Treatment will be performed as per universal standard extraction procedures without making any modifications.

Pain perceived by the children during supra-periosteal injection will be evaluated objectively using the FLACC Scale and subjective assessment of pain will be done using the Modified Wong-Baker FACES Pain Rating Scale (PRS).

The FLACC Scale is divided into 5 subgroups, each with a value between a minimum of 0 and a maximum of 2. As a result of the evaluation of each sub-parameter (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability, the total score of the FLACC Scale with a minimum of 0 and a maximum of 10 will be determined, wherein:  0 = no pain; 1–3 = mild pain; 4–6 = moderate pain; and 7–10 = severe pain. 

The Modified Wong-Baker FACES Pain Rating Scale has facial images ranging from smiling to crying, with ratings ranging from 0 to 3. While “0” indicates “no pain”, “3” indicates “severe pain”. The patient will be advised to mark the level of subjective pain on PRS immediately after administering the injection. 

In the event that the child expresses significant discomfort during the treatment, an additional dose of anesthesia will be administered. The dosage will be carefully calibrated to ensure it remains within the predetermined Maximum Recommended Dose (MRD). However, if the anesthesia fails to provide complete pain relief, the patient will be rescheduled for another day to complete the treatment in accordance with the protocol established by the department.

Upon the conclusion of both treatment appointments, comprehensive information regarding potential postoperative concerns such as pain, tongue or lip biting, hematoma, and bleeding will be imparted to both parents and children. Additionally, they will receive instructions to promptly notify the department if any of these symptoms or effects are identified.

Study Groups:

o   Group 1:

Photobiomodulation Therapy for 60 seconds + topical anesthetic gel application for 30 seconds followed by supra-periosteal injection.

 

o   Group 2:

Sham Laser for 60 seconds + topical anesthetic gel application for 30 seconds followed by supra-periosteal injection.


Hypothesis:

The null hypothesis tested in this study will be that “There will be no disparity in the perception of injection pain between extractions performed with and without the use of Photobiomodulation Therapy as an adjunct.”

 
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