| 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
|
|
|
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
|
|
|
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. |