| CTRI Number |
CTRI/2018/04/013424 [Registered on: 23/04/2018] Trial Registered Prospectively |
| Last Modified On: |
23/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to evaluate the change in pain felt by child patients when local anesthetic solution heated to 42°C before injection. |
|
Scientific Title of Study
|
Comparison of pain perception in child patients during IANB using local anaesthetic solution at room temperature and 42°C. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanwaljeet Bharti |
| Designation |
MDS student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,AHMEDABAD |
| Address |
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7203953323 |
| Fax |
|
| Email |
kamlu36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanwaljeet Bharti |
| Designation |
MDS student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,AHMEDABAD |
| Address |
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa,, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7203953323 |
| Fax |
|
| Email |
kamlu36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanwaljeet Bharti |
| Designation |
MDS student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,AHMEDABAD |
| Address |
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7203953323 |
| Fax |
|
| Email |
kamlu36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central store,
Government Dental college and Hospital,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016 |
|
|
Primary Sponsor
|
| Name |
Government |
| Address |
Government Dental College and Hospital , Ahmedabad |
| Type of Sponsor |
Other [Government Dental College ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government |
government dental college and hospital , ahmedabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shantanu Choudhari |
Government Dental college and Hospital, Ahmedabad |
Room No. 103
Department of Pedodontics and Preventive Dentistry,
Civil Hospital Campus, Asarwa, Civil Hospital Rd, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT |
9825666575
shandent1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt. Dental College & Hospital (IEC GDCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy child patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local anesthetic at 42 42°C. |
local anesthetic agent used at 42°C at first visit for inferior alveolar nerve block |
| Comparator Agent |
local anesthetic at room temperature |
Local anesthetic at room temperature during inferior alveolar nerve block in 2nd visit in same patient.
pain perception will be evaluated by visual analogue scale |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy child patients requiring routine dental treatment especially without known history of hypersensitivity to local anaesthetic lidocaine.
patients that need bilateral pulpotomy or extraction of teeth in mandibular molars requiring local anaesthetics (LA) with 2% lidocaine with 1: 2,00,000 epinephrine. |
|
| ExclusionCriteria |
| Details |
patients having systemic ailment.
Patients having known allergy to Local anesthetic lidocain.
patients who does not require local anesthetic for treatment.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient May Feel Less Pain During Local Anesthesia administration At 42°C |
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Injection fear may reduce in child patients |
5 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/04/2018 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applied for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Local anaesthetic cause pain during administration into soft tissue and this leads to stress and discomfort especially in child patients. This pain can be reduced easily and effectively by heating the local anaesthetic solution up to body temperature or above.Warming lidocaine causes no chemical denaturation or no diminished stability stated by one lidocaine manufacturer (Elkins-Sinn, Inc, Cherry Hill, NJ). This method reduces burning sensation in orthography, angiography and other interventional procedures by warming lidocaine to 43°C before infiltrative injection. We are planning to use this method to reduce discomfort during nerve block in pediatric dental patients. This study will include 60 child patients of age 6-10 years in which pain perception will be evaluated during Inferior alveolar nerve block using warm local anaesthetic at 42°C. During first visit the children will receive IANB block consisting of lidocaine 2% and epinephrine 1:2,00,000 at room temperature. At the second visit, the contralateral side will receive local anaesthetic warmed at 42°C. 15 cm long visual analogue scale will be used to determine the pain from injection given. We are hopeful that this method will work on pediatric dental setting also. |