| CTRI Number |
CTRI/2025/04/085469 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Effectiveness of Acupressure and Distraction technique in children with gag reflex |
|
Scientific Title of Study
|
Effectiveness of Acupressure and Distraction technique in children with gag reflex a prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Spruha DESHPANDE |
| Designation |
Post Graduate student |
| Affiliation |
Bharati Vidyapeeth Dental College, Pune |
| Address |
Bharati Vidyapeeth Deemed to be university Dental College and hospital , Pune , Department of Pediatric and Preventive dentistry
Pune
MAHARASHTRA
411043
India |
| Phone |
9421012081 |
| Fax |
|
| Email |
spruhasandeshpande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Laxmi Lakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Dental College, Pune |
| Address |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital,Pune, Department of Pediatric and Preventive Dentistry
Pune
MAHARASHTRA
411043
India |
| Phone |
9423508535 |
| Fax |
|
| Email |
laxmi.lakade@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Spruha DESHPANDE |
| Designation |
Post Graduate student |
| Affiliation |
Bharati Vidyapeeth Dental College, Pune |
| Address |
Post Graduate student, Department of Pediatric and Preventive Dentistry,Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune
MAHARASHTRA
411043
India |
| Phone |
9421012081 |
| Fax |
|
| Email |
spruhasandeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University Dental College, and Hospital, Pune, 411043, India |
|
|
Primary Sponsor
|
| Name |
Spruha Deshpande |
| Address |
B-33 Hastipuram , near Bibwewadin police station Bibwewadi, 411037, India |
| Type of Sponsor |
Other [Self funded, Funding would be done by principal Investigator] |
|
|
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 Spruha Deshpande |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune |
Department of Pediatric and Preventive Dentistry, 208
Pune
MAHARASHTRA |
9421012081
spruhasandeshpande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University, Pune dental Collge and Hospital , Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupressure device and L14 acupoint |
Acupressure will be applied at acupoint L14 during maxillary impression making procedure for 2 minutes |
| Comparator Agent |
Stress ball distraction technique |
After GSI is measured , during maxillary impression making, for 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Gag Severity Index IV and above
Patient requiring Maxillary impression for further treatment |
|
| ExclusionCriteria |
| Details |
Children younger than 8 years and older than 10 years
Differently abled children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of L14 acupoint and distraction technique in reducing gag reflex |
During the same day when intervention is used |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between effectiveness of distraction technique & acupressure technique |
During the same day the intervention is applied |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2025 |
| Date of Study Completion (India) |
12/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
The gag reflex is a
defensive and physiological system that protects the pharynx, larynx, and
trachea from invading noxious stimuli or foreign objects. Gagging may be caused by either somatic or
psychological factors. Somatic gagging can occur due to the stimulation of the
trigger zones around the oropharynx and psychogenic gagging can occur due to
any thought, smell, sound, or sight. A hyperactive gag
reflex can make dental treatments difficult such as a simple examination, or
even difficult procedures such as impressions leaving the patient unwilling to
accept complex clinical procedures especially in children .So the aim of the
study is to compare the effectiveness of acupressure technique on acupoint LI4
and distraction technique to reduce gag reflex. |