| 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
|
|
|
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
|
|
|
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 1Â min. After waiting for further 1Â min, local anesthetic will be injected.
|
| Intervention |
Vibration using speech stimulator |
Vibrations will be given for 1Â 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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [spra905@gmail.com].
- 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.
- 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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