| CTRI Number |
CTRI/2025/06/089124 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To assess the feeling of pain on injection of softened and preheated local anesthetic solution for the children who are undergoing baby (milk teeth) root canal treatment |
|
Scientific Title of Study
|
Assessment of efficacy of prewarmed anesthetic solution and buffered anesthetic solution on precooled injection site in paediatric patients for inferior alveolar nerve block- A Randomized split mouth control 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 Sowmiya M |
| Designation |
Pg Student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST road Chinna Kolambakkam Palayanoor (PO) Chengalpattu (DT) Department of Paediatric and Preventive Dentistry. Room no :8
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381507301 |
| Fax |
|
| Email |
ish152847@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vignesh guptha. R |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST road Chinna Kolambakkam Palayanoor (PO) Chengalpattu (DT) Department of Paediatric and Preventive Dentistry. Room no :8
Kancheepuram
TAMIL NADU
600035
India |
| Phone |
9840485769 |
| Fax |
|
| Email |
vigneshguptha88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmiya M |
| Designation |
Pg Student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST road Chinna Kolambakkam Palayanoor (PO) Chengalpattu (DT) Department of Paediatric and Preventive Dentistry. Room no :8
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381507301 |
| Fax |
|
| Email |
ish152847@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna Kolambakkam, Palayanoor post, Chengalpattu District, 603308 |
|
|
Primary Sponsor
|
| Name |
Dr sowmiya M |
| Address |
Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor post, Chengalpattu District, 603308. |
| 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 sowmiya M |
Karpaga Vinayaga Institute of Dental Sciences |
Karpaga Vinayaga Institute of Dental Sciences GST road Chinna Kolambakkam Palayanoor (PO) Chengalpattu (DT) Department of Paediatric and Preventive Dentistry. Room no :8
Kancheepuram
TAMIL NADU |
6381507301
ish152847@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional local anesthetic technique |
conventional 2% lignocaine injected in paediatric patients for inferior alveolar nerve block after topical local anesthetic agent in mandibular primary molars |
| Intervention |
Pre-warmed anesthetic solution and Buffered anesthetic solution |
pre-warmed conventional local anesthetic solution and buffered conventional local anesthetic solution using sodium bicorbonate injected on precooled injection site ( using ice tubes) in pediatric patients who need inferior alveolar nerve block for pulp theraphy bilaterally. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with symptomatic irreversible pulpitis in primary mandibular first or second molar bilaterally.
2. Patient between the age group of 5-12 years.
3. Frankel behaviour rating scale : positive and definitely positive.
4. No previous history of receiving dental injections.
|
|
| ExclusionCriteria |
| Details |
1. Children with history of medically compromising conditions.
2. Medical history suggestive of known or suspected allergies to lignocaine.
3. Patient who had taken analgesics within 24hour preceding the commencement of the endodontic procedure.
4. Any abscess or swelling involving the tooth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Injecting pre warmed or buffered local anesthetic solution on precooled injection site (less pain perception) can be a better alternative to conventional local anesthetic technique |
At the time of injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| early onset of pre warmed or buffered local anesthetic solution on precooled injection site & it can be a better alternative to conventional local anesthetic technique. |
after 2 to 3 minutes of injection |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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 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
|
Group 1: prewarmed vs conventional local anesthetic solution; Group 2: buffered vs conventional local anesthetic solution; Group 3: prewarmed vs buffered local anesthetic solution; A split mouth randomized control trial will be conducted on 120 children, 5 to 12 years of age requiring pulp therapy bilaterally on primary mandibular molars. The participants are selected from the patient reporting to the department of paediatric and preventive dentistry. The study will be carried out with the help of two investigators. The first investigator will select the patient and the selected patient will be randomly divided into 3 equal groups (Group 1, 2, 3) having 40 patients in each group. Randomization will be done using lottery method and the child will be recruited for the study. Once the group was selected, the site for precooling the injection site and for the administration of local anesthetic solution will be selected randomly by coin toss method. This would determine which technique should be administered on first appointment. The alternate technique will be administered during second appointment. The second investigator will assess the anesthetic efficacy, pain during injection and pulp therapy |