| CTRI Number |
CTRI/2025/10/095680 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Other (Specify) [Laser] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Faster Recovery from Dental Anesthesia Using Low-Level Laser Therapy |
|
Scientific Title of Study
|
Postoperative recovery with low-level laser therapy in reversing the anesthetic effect of 4 percent articaine: a randomized clinical trial |
| Trial Acronym |
Dr. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit khairnar |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Department of Pediatric and Preventive Dentistry Peoples College of Dental Sciences and Research Centre
Department of Pediatric and Preventive Dentistry Peoples College of Dental Sciences and Research Centre
Bhopal
MADHYA PRADESH
402038
India |
| Phone |
9423126755 |
| Fax |
|
| Email |
khairnarrohit590@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit khairnar |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Department of Pediatric and Preventive Dentistry Peoples college of Dental Sciences and Research Center, Bhopal
Department of Pediatric and Preventive Dentistry Peoples college of Dental Sciences and Research Center, Bhopal
Bhopal
MADHYA PRADESH
402038
India |
| Phone |
9423126755 |
| Fax |
|
| Email |
khairnarrohit590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit khairnar |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Dental Sciences and Research Center |
| Address |
Department of Pediatric and Preventive Dentistry Peoples college of Dental Sciences and Research Center, Bhopal
Department of Pediatric and Preventive Dentistry Peoples college of Dental Sciences and Research Center, Bhopal
Bhopal
MADHYA PRADESH
402038
India |
| Phone |
9423126755 |
| Fax |
|
| Email |
khairnarrohit590@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Dental Sciences and Reseach Center |
|
|
Primary Sponsor
|
| Name |
Peoples College of Dental Sciences and Research Center Bhopal |
| Address |
Peoples College of Dental Sciences and Research Center, Bhopal, Madhya Pradesh, India, Pincode-462038 |
| 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 Rohit Khairnar |
Peoples college of Dental Sciences and Research Center, Bhopal |
Department of Pediatric and Preventive Dentistry Peoples college of Dental Sciences and Research Center, Bhopal
Bhopal
MADHYA PRADESH |
9423126755
khairnarrohit590@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College of Dental Sciences and Research Center, Bhopla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient undergoing Dental procedure and requirement of Anesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Checking the normal reversal of Anesthetic effect of 4% Articaine as Dental Anesthetic Agent |
Assessment of Anesthetic Reversal and Recovery:
The recovery of soft-tissue sensation following 4% articaine administration will be assessed every 10 minutes for up to 2 hours or until full recovery. The following parameters will be recorded:
a) Lip Tapping Test: To check for return of sensation every 10 minutes.
b) Two-Point Discrimination: Comparison between anesthetized and normal sides.
c) Current Perception Threshold (CPT): A painless TENS-based test (5 Hz, 0–10 range) to determine sensory threshold.
d) Pediatric Functional Assessment: Evaluation of dysphagia (drinking 90 ml water), dysarthria (saying ten words), dysphonia (grinning), and nausea.
e) Soft-Tissue Injury Check: A 24-hour follow-up will be done to detect any accidental biting or trauma.
All observations will be recorded, and time to complete sensory and functional recovery will be documented for both groups. |
| Intervention |
Checking the Reversal of anesthetic effect 4% Articaine using Photo biomodulation as Dental Anesthetic Agent |
Assessment of Anesthetic Reversal and Recovery (Intervention Group – Group A):
The recovery of soft-tissue sensation following 4% articaine administration will be evaluated in patients receiving a single session of low-level laser therapy (650 nm, 100 mW). Assessments will be performed every 10 minutes for up to 2 hours or until complete recovery is achieved.
a) Lip Tapping Test: Conducted every 10 minutes to note return of sensation.
b) Two-Point Discrimination: Comparison between the anesthetized and normal sides.
c) Current Perception Threshold (CPT): Measured using a TENS device at 5 Hz, with adjustable intensity (0–10) until the child perceives the first electrical stimulus.
d) Pediatric Functional Assessment: Evaluation of dysphagia (drinking 90 ml water), dysarthria (pronouncing ten words), dysphonia (grinning broadly), and nausea.
e) Soft-Tissue Injury Check: A 24-hour follow-up will be conducted to detect any lip, tongue, or cheek trauma.
All findings will be documented, and the time to complete sensory and functional recovery will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children undergoing dental procedure which requires local anesthesia.
Children with no relevant medical history.
Frankel behavior score of 3 and 4.
|
|
| ExclusionCriteria |
| Details |
Children with previous history of photosensitivity.
Children with systemic diseases and illness (with pacemaker or any other electromagnetic devices).
Frankel behavior score of 1 and 2.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there should be reduction in duration of anesthetic effect after laser application |
every 10-15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/03/2026 |
| 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="1"
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
|
METHODOLOGY- A randomized clinical trial will be conducted on sample size of 60 children with age group of 5-8 years undergoing dental procedures which requires local anaesthesia administration. Patients included in the study will be divided randomly into two groups according to use of postoperative LASER to nullify the effect of 4% Articaine. Group A: Local anesthesia with 4% articaine and the use of a diode laser for the reversal of its effect. Group B: Local anesthesia with 4% articaine without the use of a diode laser for the reversal of its effect. Procedure: - Patients will be advised to take an analgesic before treatment to prevent pain once the anaesthetic effect wears off. All patients will first receive a nerve block with local anesthesia (4% Articaine). Half a cartridge will be administered to patients weighing between 15 kg to 30 kg, while a full cartridge (1.7 ml) will be given to children weighing more than 30 kg. The dental procedure will be performed following a standardized protocol in 40 minutes. Group A will be the experimental group, where LASER will be used for the reversal of anesthesia, and the patient will be monitored until he/she regains sensation. Group B will be the control group, where LASER will not be used for the reversal of anesthesia, and the patient will be monitored until he/she regains sensation. Regaining of sensation will be check by a)Lip taping: Every 10 min for 2 hr after exposure or until the patient senses the lip tapping. b)Two-point discrimination: Comparison between normal side with anaesthetic side. c)Current Perception Threshold: A painless transcutaneous electro-diagnostic sensory threshold test of the peripheral nervous system using TENS. An electric stimulus will be administered at a frequency of 5 Hz. The current intensity will be controlled via an adjustable regulator switch with a range of 0-10 until a shock sensation is felt by the child. d)Paediatric Function Assessment Battery: The child will be assessed for functional impairments such as dysphagia (evaluated by drinking 90 ml of water), dysarthria (assessed by saying ten words), dysphonia (checked by grinning broadly), and nausea. e)Soft tissue injury assessments: Soft tissue injury assessment will be conducted through a 24-hour follow up.
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