| CTRI Number |
CTRI/2026/04/109086 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two numbing medicines used with laser to reduce pain during treatment of painful milk teeth in children |
|
Scientific Title of Study
|
Anaesthetic Success Of Laser Assisted Lignocaine And Articaine In Deciduous Molar With Symptomatic Irreversible Pulpitis: A Randomized Comparative Clinical Study |
| 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 Rahul Solanki |
| Designation |
post graduate student |
| Affiliation |
Karnavati School of Dentistry, Karnavati University |
| Address |
department of pediatric and preventive dentistry Karnavati School of Dentistry, B Block, Karnavati University, A-907 Adalaj-Uvarsad Road, Gandhinagar, Gujarat 382422, India
Gandhinagar
GUJARAT
382422
India |
| Phone |
7574074635 |
| Fax |
|
| Email |
rahulsolanki15699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR megha Patel |
| Designation |
HOD of department of pediatric and Preventive dentistry |
| Affiliation |
Karnavati School of Dentistry, Karnavati University |
| Address |
Karnavati School of Dentistry, B Block, Karnavati University, A-907 Adalaj-Uvarsad Road, Gandhinagar, Gujarat 382422, India
Gandhinagar
GUJARAT
382422
India |
| Phone |
7574074635 |
| Fax |
|
| Email |
drmegha1782@Gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Rahul Solanki |
| Designation |
post graduate student |
| Affiliation |
Karnavati School of Dentistry, Karnavati University |
| Address |
department of pediatric and preventive dentistry ,Karnavati School of Dentistry, B Block, Karnavati University, A-907 Adalaj-Uvarsad Road, Gandhinagar, Gujarat 382422, India
Gandhinagar
GUJARAT
382422
India |
| Phone |
7574074635 |
| Fax |
|
| Email |
rahulsolanki15699@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krnvti shool of Dentistry, 907, Uvrd dlj Rod, Gndhingr, 382422 Gujrat India |
|
|
Primary Sponsor
|
| Name |
Dr Rahul Solanki |
| Address |
Madhav Farm, Longdi-Bhguda Road, Village: Bhguda Ta: Mahuva, D: Bhavnagar,Gujrat india pin code 364295 |
| 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 Rahul Solanki |
karnavati school of dentistry |
department of pediatric and preventive Dentistry, Karnavati School of Dentistry, B Block, Karnavati University, A-907 Adalaj-Uvarsad Road, Gandhinagar, Gujarat 382422, India
Gandhinagar
GUJARAT |
07574074635
rahulsolanki15699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| karnavati school of dentistry ETHICS COMMITTEE |
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 |
| Comparator Agent |
IANB combined with buccal infiltration using 2% lidocaine |
inferior alveolar nerve block (IANB) will be administered in standardized manner with 2% Lidocaine containing 1:100.000 by using 27-gauge needle. For standardization 1.8ml of anesthetic solution will be deposited at rate of 1ml/min in all cases,total duration of study is 9 month |
| Intervention |
IANB using 4% articaine with Low-Level Laser Therapy (LLLT) |
Inferior Alveolar Nerve Block (IANB) using 2% lidocaine with Low-Level Laser Therapy (LLLT), Inferior Alveolar Nerve Block (IANB) using 4% articaine with Low-Level Laser Therapy (LLLT) and IANB combined with buccal infiltration using 2% lidocaine in mandibular molar with symptomatic irreversible pulpitis,total duration of study is 9 month |
| Intervention |
IANB with lignocaine and LLLT |
Inferior Alveolar Nerve Block (IANB) using 2% lidocaine with Low-Level Laser Therapy (LLLT), Inferior Alveolar Nerve Block (IANB) using 4% articaine with Low-Level Laser Therapy (LLLT) and IANB combined with buccal infiltration using 2% lidocaine in mandibular molar with symptomatic irreversible pulpitis ,total duration of study is 9 month |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children, aged between 4 to 8 years.
2. Symptomatic irreversible pulpitis in deciduous second mandibular molars.
3. Teeth with hyperresponsive pulp to thermal/electric pulp testing.
4. No periapical pathology (swelling, or radiolucency).
5. Restorable crown structure of the tooth.
6. Co-operative children who can understand and respond using pain scales (wong-baker faces scale).
|
|
| ExclusionCriteria |
| Details |
1. Children aged less than 4 or more than 8 years.
2. Asymptomatic teeth.
3. With periapical abscess, internal/external resorption, or pathological mobility.
4. Non-restorable teeth or those that are indicated for extraction.
5. Allergy to any of the local anesthetic drugs used in the study in children.
6. Systemic disease in children.
7. Uncooperative children or having special health care needs or psychological illness.
8. Patients on long-term analgesic or antibiotic treatment.
9. Previous endodontic treatment in the same tooth.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the success of Inferior Alveolar Nerve Block (IANB) using 2% lidocaine with Low-Level Laser Therapy (LLLT), Inferior Alveolar Nerve Block (IANB) using 4% articaine with Low-Level Laser Therapy (LLLT) and IANB combined with buccal infiltration using 2% lidocaine in mandibular molar with symptomatic irreversible pulpitis. |
0-pre treatment
1-during treatment
2-post treatment at the base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure & compare pain perception during access opening & initial instrumentation using the Wong–Baker Faces Pain Rating Scale & FLACC scale (face, legs,activities,cry, consolability) in all 3 groups.
To evaluate the level of child cooperation & comfort during treatment using houpt behaviour rating scale in each group.
To assess whether any intraoperative supplementary infiltration will be needed or not based on Wong–Baker Faces Pain Rating Scale.
|
0-pre treatment
1-during treatment
2-post treatment at base line |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
20/08/2026 |
| 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="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Taking dental impressions in children can be challenging due to an exaggerated gag reflex (GR), which may compromise treatment quality and patient compliance. The gag reflex can be triggered by both physical and psychological factors and is often associated with anxiety and previous negative dental experiences. Various management strategies, including behavioural techniques, pharmacological methods, and complementary therapies, have been proposed. Among these, laser acupuncture and electroacupuncture are non-invasive, safe, and effective approaches that may help reduce gag reflex and improve cooperation in pediatric patients. However, limited evidence exists comparing their effectiveness in children. Therefore, this study aims to evaluate and compare low-level laser therapy and microcurrent electrical stimulation in controlling gag reflex during dental impression procedures in children. Null Hypothesis: There is no significant difference between laser acupuncture and electroacupuncture in managing gag reflex. |