| CTRI Number |
CTRI/2025/10/096270 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Impact of Rinsing with Different Solutions Before Dental Injections on Pain in Children |
|
Scientific Title of Study
|
Comparative Evaluation of Holding Different Solutions in the Mouth on pain perception prior to Dental Injections in Children: A Randomized Controlled 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 |
Noopur Kaushik |
| Designation |
Professor |
| Affiliation |
Subharti dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7830008899 |
| Fax |
|
| Email |
drnoopurkaushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Noopur Kaushik |
| Designation |
Professor |
| Affiliation |
Subharti dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7830008899 |
| Fax |
|
| Email |
drnoopurkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Noopur Kaushik |
| Designation |
Professor |
| Affiliation |
Subharti dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7830008899 |
| Fax |
|
| Email |
drnoopurkaushik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti dental college and hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road Subharti University, Meerut
UTTAR PRADESH
250005
India |
|
|
Primary Sponsor
|
| Name |
Dr Noopur Kaushik |
| Address |
Subharti Dental College and Hospital, Swami Vivekanand Subharti University |
| 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 Noopur Kaushik |
Subharti Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road, Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
7830008899
drnoopurkaushik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold water (refrigerated water temp: 8-12 degrees) (Group 2) |
Children in this group will be asked to hold cold water (refrigerated, temperature approximately 8–12°C) in their mouth for 30–60 seconds prior to the administration of local anesthesia. |
| Comparator Agent |
Room temperature water (Group 1) |
Children in this group will be asked to hold room temperature water (approximately 25°C) in their mouth for 30–60 seconds prior to the administration of local anesthesia. |
| Intervention |
Sweet tasting solution (Group 3) |
Children in this group will be asked to hold a sweet tasting solution (prepared using sucrose solution, approximately 24% w/v) in their mouth for 30–60 seconds prior to the administration of local anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children requiring dental treatment under local anesthesia and Cooperative patients (class III & class IV on Frankle behavior rating scale) with no previous dental history. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception score measured using the Wong-Baker Facial Pain Rating Scale (WBFPS) immediately after administration of local anesthesia. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2025 |
| 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="0"
Months="3"
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
|
Downregulation of pain associated with dental injections may help reducing fear towards dentistry among pediatric population. Furthermore, it may help us to provide quality treatment and the patient to seek dental care without any hesitation or anxiety. Indefinite methods have been instituted in order to reduce pain while giving dental injections. Sweet-tasting solution given to the patient by oral route prior to giving an injection has proved to be a promising way to reduce pain time and again. Cooling of injured tissue also holds a strong place in the history of medicine. Local external cooling for pain relief has been invariably used for the management of sprains, burns, fractures, bruising, and insect bites. Regional skin cooling to reduce pain from sports injuries is a common practice. Despite the availability of numerous ways to reduce pain associated with dental injections, there is scant data about their comparison. Therefore, this study aimed to compare the pain-reducing ability of sweet-tasting solution, cold water, and room-temperature water before the administration of local anesthesia in children. The present study will be conducted to evaluate the effect of holding different solutions in the mouth prior to local anesthesia administration on pain perception in children. A total of 45 healthy children aged 6–10 years requiring dental treatment under local anesthesia will be randomly divided into three equal groups (n = 15 each). Children in Group 1 (control group) will be asked to hold room-temperature water in their mouths for 30–60 seconds before the injection. Participants in Group 2 will hold cold water, while those in Group 3 will hold a sweet-tasting solution for the same duration prior to administration of local anesthesia. Pain perception will be assessed immediately after injection using the Wong-Baker Facial Pain Rating Scale (WBFPS). Data will be statistically analyzed. |