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CTRI Number  CTRI/2025/12/098696 [Registered on: 09/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Success of light therapy for dental fear and its association with salivary enzyme levels in children 
Scientific Title of Study   Efficacy of laser acupuncture for dental anxiety and its association with salivary alpha amylase levels 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 Ramisetty Mounika 
Designation  1st MDS 
Affiliation  Vishnu Dental College  
Address  Department of Pedodontics and Preventive Dentistry Room no-5 Block no-3 Vishnu Dental College Vishnupur Bhimavaram Andhra Pradesh 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  6303830368  
Fax    
Email  mounikaramisettg17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ahalya Penmetsa  
Designation  Reader  
Affiliation  Vishnu Dental College  
Address  Department of Pedodontics and Preventive Dentistry Room no 5 Block no 3 Vishnu Dental College Vishnupur Bhimavaram Andhra Pradesh 534202

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  Reader  
Affiliation  Vishnu Dental College  
Address  Department of Pedodontics and Preventive Dentistry Room no 5 Block no 3 Vishnu Dental College Vishnupur Bhimavaram Andhra Pradesh 534202

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 Andhra Pradesh 534202 
 
Primary Sponsor  
Name  Dr Ramisetty Mounika 
Address  Department of Pedodontics and Preventive Dentistry Room no-5 Block no-3 Vishnu Dental College Vishnupur Bhimavaram Andhra Pradesh 534202 
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 Ramisetty Mounika  Vishnu Dental College   Department of Pedodontics and Preventive Dentistry Room no-5 Block no-3 Vishnu Dental College Vishnupur Bhimavaram Andhra Pradesh 534202
West Godavari
ANDHRA PRADESH 
6303830368

mounikaramisettg17@gmail.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F402||Specific (isolated) phobias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  laser acupuncture  Low level laser therapy using Diode Laser to stimulate the acupoints i.e. Shenmen and relaxation points on the auricle for duration of 30sec 
Comparator Agent  sham laser  the same fiber tip but with no active laser irradiation for duration of 30 seconds 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children with Frankl’s definitely negative and negative behavior.
2. Children with Facial image anxiety score 4-5
and MCDAS score more than 19 included in this study.  
 
ExclusionCriteria 
Details  1. Children with history of systemic diseases or mental disabilities.
2. Children with history of under medication in last months which effects the salivary gland function.
3. Children with special care need will be excluded.
 
 
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 
Anxiety levels measured pre and post laser acupuncture objectively (MCDAS) & its association with salivary alpha amylase levels.
2.Subjective Axiety levels measurement pre and post laser acupuncture using anxiety rating scales.
 
Baseline and 2 min after laser acupuncture  
 
Secondary Outcome  
Outcome  TimePoints 
Level of cooperation for completion of treatment  Baseline & 2 min after laser acupuncture  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   20/12/2025 
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="8"
Days="7" 
Recruitment Status of Trial (Global)   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  

Dental fear and anxiety can result in avoidance of treatment, leading to a significantly stressful experience for the child. Dental anxiety assessment can be done by various methods, like objective (blood pressure, heart rate using pulse oximeter, salivary biomarkers) and subjective strategies (anxiety rating scales). They are the Venham Picture Test, Facial Image Scale, Modified Child Dental Anxiety Scale, Children Fear Survey Schedule-Dental Subscale, Hamilton Anxiety Rating Scale. Dental anxiety can be managed by various methods including relaxation, acupressure, distraction, behavioural techniques, acupuncture and laser acupuncture. Laser acupuncture is a non-invasive treatment that uses a low intensity laser beam to stimulate acupuncture points instead of a needle. Various anti-anxiety points which are tried & tested are Shen men point, relaxation point, extra-one point, union valley point, shoulder well point, great surge point, Nei guan point. This study was planned to evaluate the efficacy of laser acupuncture for dental anxiety management during various treatment procedures in children of age 6 to 12 yrs. Children from OPD in the Department of Paediatric and Preventive Dentistry will be screened. Based on inclusion and exclusion criteria, 42 children aged 6-12 years will be recruited into the study. The children will be allocated into 2 groups- Group-1: Sham laser acupuncture & Group-2: laser acupuncture. Pre & post operatively heart rate will be assessed with pulse oximeter, dental anxiety will be assessed using modified child dental anxiety scale (8-12 yrs), facial image scale (6-8 yrs).  With patient in upright position, Salivary samples are collected using drooling method and subjected to ELISA for estimation of salivary alpha amylase levels pre & post operatively. Acupoints will be located and marked followed by laser stimulation of acupoints.

 
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