| CTRI Number |
CTRI/2026/01/102519 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two acupressure points for pain relief during dental nerve block injections |
|
Scientific Title of Study
|
Effectiveness of two acupressure points on pain experience during inferior alveolar nerve block injection in children aged 6-8 years – 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 |
Sayali Nandangiri |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
301, Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440016 India |
| Phone |
9284373882 |
| Fax |
|
| Email |
spnandangiri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
301, Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440016 India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
301, Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440016 India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur, Maharashtra, India-440016 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur, Maharashtra, India-440016 |
| Type of Sponsor |
Private medical college |
|
|
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 Sayali Nandangiri |
301, Department of Pediatric and Preventive Dentistry |
Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur, Maharashtra, India-440016 Nagpur MAHARASHTRA |
09284373882
spnandangiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
acupressure at extra-1 acupoint |
Acupressure at the Extra-1 (Yintang) acupoint creates a calming and reassuring atmosphere within the dental setting. The Extra-1 point, located between the eyebrows, is gently stimulated using finger pressure or acupressure devices prior to or during dental procedures. This non-invasive technique promotes relaxation by reducing psychological stress and anxiety, helping patients feel more at ease despite the surrounding dental stimuli. By inducing a sense of calmness and emotional balance, acupressure at the Extra-1 acupoint can lower apprehension, improve patient cooperation, and enhance overall comfort during dental treatment, particularly in individuals who are anxious or sensitive to the dental environment |
| Intervention |
acupressure at LI4 acupoint |
Acupressure at the LI4 (Hegu) acupoint contributes to a calming and pain-modulating dental environment. The LI4 point, located between the thumb and index finger, is gently stimulated using sustained finger pressure or an acupressure aid before or during dental procedures. This stimulation is known to promote relaxation and reduce the perception of pain and anxiety by influencing neural pathways associated with stress and discomfort. By alleviating tension and enhancing the patient’s coping ability, acupressure at the LI4 acupoint helps counteract the stress-provoking elements of the dental setting, improves patient cooperation, and supports a more comfortable and positive dental treatment experience. |
| Comparator Agent |
tell-show-do technique |
The Tell–Show–Do technique creates a supportive and non-threatening dental environment by systematically introducing patients to dental procedures. In the tell phase, the dentist explains each step using simple, age-appropriate, and non-frightening language. During the show phase, instruments and procedures are demonstrated visually or tactically outside the oral cavity, allowing the patient to see, hear, or feel what will happen in a controlled manner. Finally, in the do phase, the procedure is performed exactly as explained and demonstrated. This predictable and transparent approach reduces fear of the unknown, builds trust between the patient and the dentist, minimizes anxiety, and enhances patient cooperation during dental treatment. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
- children indicated for dental procedure requiring inferior alveolar nerve block injection
- children who exhibits Frankl behavior rating three or four and with faces version of MCDAS score more than or equal to 30 |
|
| ExclusionCriteria |
| Details |
Active infection at the site of injection
Children with known history to allergy to any topical or local anesthetic agent.
Uncooperative children.
Patient having acute pain on the day of procedure.
Patients with blisters, rashes, open wounds, and swelling in and around area of acupressure points. |
|
|
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 experienced by children aged 6–8 years during inferior alveolar nerve block injection, used to evaluate and compare the effectiveness of acupressure at the Extra-1 point and the LI4 point |
at baseline, during treatment and post operatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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
|
The purpose of the present study is to evaluate and compare the effectiveness of acupressure at the Extra-1 point and the LI4 point in reducing pain experienced by children aged 6 to 8 years during inferior alveolar nerve block injections. |