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CTRI Number  CTRI/2024/10/075357 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Evaluation of Pain Reduction using different pre anesthetic preparations -A Randomised Controlled Trial 
Scientific Title of Study   Comparative Evaluation of Pain Reduction with Vibration using Speech Simulator versus 2 percent Lignocaine Topical Gel Application Prior to Greater Palatine Nerve Block in 7 to 12 year Old Children-A Randomised 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  Dr Santhosh Prasanth 
Designation  Assistant Professor 
Affiliation  Government Dental College, Trivandrum 
Address  Government Dental College, Medical College PO. Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9447212649  
Fax    
Email  spra905@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santhosh Prasanth 
Designation  Assistant Professor 
Affiliation  Government Dental College, Trivandrum 
Address  Government Dental College, Medical College PO. Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9447212649  
Fax    
Email  spra905@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Santhosh Prasanth 
Designation  Assistant Professor 
Affiliation  Government Dental College, Trivandrum 
Address  Government Dental College, Medical College PO. Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9447212649  
Fax    
Email  spra905@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College, Medical College PO, Trivandrum, Kerala, India, PIN 695011 
 
Primary Sponsor  
Name  Dr Santhosh Prasanth 
Address  Department of Pedodontics, Government Dental College, Medical College PO. Thiruvananthapuram 
Type of Sponsor  Other [Other (Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santhosh Prasanth  Government Dental College, Thiruvananthapuram  Department of Pedodontics, Room 401, Government Dental College, Medical College PO. Thiruvananthapuram
Thiruvananthapuram
KERALA 
9447212649

spra905@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutioinal Ethics Committee, Government Dental College, Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocain topical gel  A total of 0.2-ml lignocaine 2% gel will be applied with a cotton roll on the dry oral mucosa for 1 min. After waiting for further 1 min, local anesthetic will be injected.  
Intervention  Vibration using speech stimulator  Vibrations will be given for 1 min before injection, and patient will continue to receive vibrations during injection. For vibration application, the head of the speech stimulator will be covered with any one of the finger parts of a disposable glove, speech stimulator switched on, and vibration will be applied with the mouth piece facing onto the oral mucosa, as close as possible to the site of the injection. Once the procedure is over, the glove will be discarded so that the speech stimulator could be reused after chemical sterilization.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children of 7-12 years.
Children with Frankl behaviour rating scale of 3 or 4
Children who require Greater palatine nerve block as part of their treatment plan.
Children belonging to ASA 1 group and having no history of allergy to local anaesthetic solutions. 
 
ExclusionCriteria 
Details  Parent not willing to give consent.
Patients below 6 years of age
Children with uncooperative behaviour
Medically compromised children 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain will assess in FPS scale and SEM scale  Pain will assess in FPS scale and SEM scale 
 
Secondary Outcome  
Outcome  TimePoints 
Discomfort  1 minute after the intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) 06/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/02/2025 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [spra905@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   DETAILED METHODOLOGY

 Group A: Vibrations will be given for 1 min before injection, and patient will continue to receive vibrations during injection. For vibration application, the head of the speech stimulator will be covered with any one of the finger parts of a disposable glove, speech stimulator switched on, and vibration will be applied with the mouth piece facing onto the oral mucosa, as close as possible to the site of the injection. Once the procedure is over, the glove will be discarded so that the speech stimulator could be reused after chemical sterilization.

Group B :A total of 0.2-ml lignocaine 2% gel  will be applied with a cotton roll on the dry oral mucosa for 1 min. After waiting for further 1 min, local anesthetic will be injected.
All these applications will be followed by injection of 2% lignocaine HCl with 1:80,000 adrenaline at the same site using standard 2 ml syringe and 26-gauge, 1/2-inch needle in all the groups. All injections with topical applications/vibration will be administered on palatal mucosa. Tissues will be dried with cotton gauze before application of any agent. Two researchers will be conducting the study, of which the primary researcher will perform all the injections.
Second researcher is an impartial observer who will evaluate the pain during injection using SEM (sound, eye, motor) scale. At the end of  palatal injections, each patient will be asked by the second researcher about the pain experience during injection using Faces Pain Scale (FPS). In SEM scale sound, eye and motor pain reactions of patient will be observed. The reactions will be classified on a scale from 1 to 4 categories: comfort, mild discomfort, moderately painful, and painful for each of the S, E, and M code (Table 1). The S, E, and M values of a child will be added to get SEM score for that child. The second researcher standing at a distance of 1.5 m from the dental chair will evaluatethe patient’s sounds, eye signs, and body movements during injection (Abdelmoniem & Mahmoud 2016).
FPS Scale
The FPS is a self-report measure of pain intensity developed for children across the age range of 4–16 years which scores the sensation of pain on the widely accepted 0 to 10 metric (Garra et al. 2010; Abdelmoniem & Mahmoud 2016). Following the recording of both the scores, the required maxillary tooth will be extracted.


 
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