| CTRI Number |
CTRI/2023/01/049239 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a chemical on dental pain when added to regular anesthesia injection in children. |
|
Scientific Title of Study
|
Evaluation of effect of addition of magnesium sulphate to lignocaine hydrochloride on pulpal anesthesia achieved after administration of inferior alveolar nerve block in children: a prospective, split mouth, randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghuram Chilukuri |
| Designation |
2nd year post graduate student |
| Affiliation |
Manipal College Of Dental Sciences Manipal |
| Address |
Department of Pediatric and preventive dentistry Manipal college of dental sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9177477093 |
| Fax |
|
| Email |
raghudrchilukuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Pai |
| Designation |
Associate professor |
| Affiliation |
Manipal College Of Dental Sciences Manipal |
| Address |
Department of Pediatric and preventive dentistry Manipal college of dental sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9741157123 |
| Fax |
|
| Email |
deepikapai0479@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghuram Chilukuri |
| Designation |
2nd year post graduate student |
| Affiliation |
Manipal College Of Dental Sciences Manipal |
| Address |
Department of Pediatric and preventive dentistry Manipal college of dental sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9177477093 |
| Fax |
|
| Email |
raghudrchilukuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Dr Raghuram Chilukuri |
| Address |
Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Deepika Pai |
Department of pediatric and preventive dentistry Manipal college of dental sciences Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raghuram chilukuri |
Manipal College of Dental sciences |
Room number 6 PG section Department of Pediatric and preventive dentistry Manipal college of dental sciences Manipal
Udupi
KARNATAKA |
9177477093
raghudrchilukuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
addition of magnesium sulphate to lignocaine local anesthesia |
0.18ml of magnesium sulphate 2mg/kg is added to 2% lignocaine hydrochloride local anesthesia and given in Inferior alveolar nerve block that acts for a duration of 1 hour after administration. |
| Comparator Agent |
sterile distilled water added to lignocaine hydrochloride local anesthesia |
0.18ml sterile distilled water is added to 1.8ml cartridge of 2% lignocaine hydrochloride local anesthesia and given in inferior alveolar nerve block that acts for a duration of 1 hour after administering nerve block |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Patients in 6 years to 9 years of age group with ability to understand pain record scales With positive or definitely positive behavior as per Frankel behavior rating scale With parental consent With primary mandibular second molars showing symptoms of irreversible pulpitis having lingering response to cold test With moderate to severe pain in Heft Parker Visual Analogue scale after cold test With no radiographic alterations of periodontal ligament space and fully formed roots |
|
| ExclusionCriteria |
| Details |
Patients having history of allergies to magnesium sulphate or local anesthesia or other medications Uncooperative patients Patients having history of significant medical conditions Patients taking beta blockers and opioids preoperatively Patients with primary mandibular second molars with signs of irreversible pulpitis with no pain responding normally to cold test Presence of periodontal ligament space enlargement and presence of periapical radiolucency in radiographic examination |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is to evaluate and compare the effect of pulpal anesthesia achieved when inferior alveolar nerve block is given with lignocaine hydrochloride containing magnesium sulphate to that of inferior alveolar nerve block containing lignocaine hydrochloride without magnesium sulphate in treatment of irreversible pulpitis in primary mandibular second molars. Pulpal Pain levels of the patient while performing pulpectomy procedure will be assessed after intervention.
|
Pain levels will be assessed for a span of 1 hour while doing pulpectomy after administering nerve block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is the onset duration and adverse affects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia in inferior alveolar nerve block |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/02/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, split mouth, double blinded, randomized control trial to evaluate the effect of addition of 0.18ml of 2mg/kg magnesium sulphate to 2% lignocaine hydrochloride on pulpal anesthesia achieved after administration of inferior alveolar nerve block in children having irreversible pulpitis in primary mandibular second molars. Study will be done in a single center in Manipal, India with a sample size of 35 children. The primary outcome measures will be to evaluate and compare the effect of pulpal anesthesia achieved when magnesium sulphate is added to lignocaine hydrochloride local anesthesia to that of a regular lignocaine local anesthesia. Secondary outcome measures will be to measure the onset, duration of anesthesia and adverse effects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia. |