| CTRI Number |
CTRI/2025/07/091651 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing pain relief methods of local anesthetic injection before dental procedures in children, a study of vibratory toothbrush, light therapy, and numbing gel |
|
Scientific Title of Study
|
Comparative evaluation of vibratory toothbrush and photobiomodulation with topical anesthetic gel as preanesthetic tissue management in 5–12-year-old children undergoing dental procedure – an in vivo study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/MBDC/01/03/2025/001/27/03/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAGHA SURESH |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MAR BASELIOS DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
MAR BASELIOS DENTAL COLLEGE THANGALAM
KOTHAMANGALAM
ERNAKULAM
KERALA
671310
Ernakulam
KERALA
686691
India |
| Phone |
09544971446 |
| Fax |
|
| Email |
anaghasureshammu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. KORATH ABRAHAM |
| Designation |
HOD |
| Affiliation |
MAR BASELIOS DENTAL COLLEGE |
| Address |
PROFESSOR AND HOD
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
MAR BASELIOS DENTAL COLLEGE THANGALAM
KOTHAMANGALAM
ERNAKULAM
KERALA
671310
Ernakulam
KERALA
686691
India |
| Phone |
09544971446 |
| Fax |
|
| Email |
anaghasureshammu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANAGHA SURESH |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MAR BASELIOS DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
MAR BASELIOS DENTAL COLLEGE THANGALAM
KOTHAMANGALAM
ERNAKULAM
KERALA
671310
Ernakulam
KERALA
686691
India |
| Phone |
09544971446 |
| Fax |
|
| Email |
anaghasureshammu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR Anagha Suresh |
| Address |
MAR BASELIOS DENTAL COLLEGE
THANGALAM
KOTHAMANGALAM
ERNAKULAM
KEREALA
686691 |
| 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 |
| ANAGHA SURESH |
Mar Baselios Dental College |
Kothamangalam
Ernakulam
Kerala
686691
Ernakulam
KERALA |
09544971446
anaghasureshammu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MEDICALLY FIT |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode laser |
Epic Biolase X; Technology, Inc., USA |
| Intervention |
photobiomodulation |
Diode laser (Epic Biolase X; Technology, Inc., USA) |
| Comparator Agent |
topical anesthetic gel |
Pepsodent Lignospan O, Mumbai, India
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children with age range between 5 and 12 years old.2)Children with written informed consent forms given by a parent or guardian.3)Childrens dental behavior score of 3 or 4 according to the Frankel behavior rating scale.4)Children who need local anesthesia for dental treatment in three quadrants of the oral cavity. |
|
| ExclusionCriteria |
| Details |
1)History of allergy to material used for anesthesia and sulfite.2)Children who have any systemic disease or special health care need.
3)Presence of any inflammation or lesion at the site of injection.4)Children who had previous bad experiences with dentistry. 5)Children presenting for emergency treatment of dental pain
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| methods to reduce local anesthetic injection pain |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| experience during local anesthetic injection |
2 years |
• To evaluate the effectiveness of a vibratory toothbrush with topical anesthetic gel for reducing local anesthetic injection pain.
• To evaluate the effectiveness of photobiomodulation with topical anesthetic gel for reducing local anesthetic injection pain.
• To evaluate the effectiveness of topical anesthetic gel for reducing local anesthetic injection pain.
• To evaluate the effectiveness of vibratory toothbrush, photobiomodulation, and topical anesthetic gel for reducing local anesthetic injection pain.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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="5"
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
|
Subjects who fulfill inclusion criteria will be selected and prepared to receive and respond to three preanesthetic tissue management methods. Method 1 is using topical anesthetic gel in this some amount of gel applied directly onto a cotton swab and applied for 1 minute. Immediately after this, local anesthesia is given. Method 2 is using vibratory toothbrush. This vibration will be given for 1 minute before injection. Provide vibrations close to injection site as feasible with head’s bristles facing the oral mucosa. Method 3 is using photobiomodulation; in this, a diode laser epic X biolase technology from the USA with 0.2 W power and 940nm wavelength for 60 sec using continuous wave mode, both the operator and the patient should wear safety goggles while the laser is being radiated. After 60 sec, a local anesthetic injection is given.The local anesthesia given will be 2% lignocaine hydrochloride with 1:20000 adrenaline using a 27 gauge short needle with slow speed of 60 sec.Infiltration injection will be performed on the buccal gingiva of the approximated position of the root apex of the related. 0.5ml of anesthetic solution should be deposited in the supraperiosteal area. Buccal infiltration should be supplemented with palatal or lingual infiltration. The outcome is assessed using subjective and objective methods. |