| CTRI Number |
CTRI/2018/05/013842 [Registered on: 11/05/2018] Trial Registered Prospectively |
| Last Modified On: |
10/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of local anesthesia with added magnesium sulphate for lower wisdom teeth extraction |
|
Scientific Title of Study
|
Evaluation of efficacy of magnesium sulphate as an adjuvant to lignocaine in inferior alveolar nerve block for extraction of mandibular third molar. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrinal Ranjan |
| Designation |
Dental intern |
| Affiliation |
Manipal College of dental sciences, manipal |
| Address |
Department of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9986937286 |
| Fax |
|
| Email |
mrinal.ranjan18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanth G |
| Designation |
Associate professor |
| Affiliation |
Manipal College of dental sciences, manipal |
| Address |
Department of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9986455201 |
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srikanth G |
| Designation |
Associate professor |
| Affiliation |
Manipal College of dental sciences, manipal |
| Address |
Department of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9986455201 |
| Fax |
|
| Email |
gadi_mds@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of Dental sciences, Madhavnagar, Eshwarnagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Srikanth G |
| Address |
Department of Oral and Maxillofacial surgery, Manipal college of dental sciences, Madhavnagar, Eshwarnagar, Manipal 576104, Karnataka |
| Type of Sponsor |
Other [MCODS, Manipal] |
|
|
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 |
| Mrinal Ranjan |
Manipal College of Dental sciences, Manipal |
Department number 4, Department of oral and maxillofacial surgery
Udupi
KARNATAKA |
9986937286
mrinal.ranjan18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC & KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bilateral impacted mandibular third molars , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine |
Lignocaine in the concentration 1:200,000
Injected once before the procedure |
| Comparator Agent |
Magnesium sulphate with lignocaine |
0.2ml magnesium sulphate with 1.8ml lignocaine of the concentration 1:200,000
Injected once before the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients who require extraction of mandibular third molars on both left and right side. |
|
| ExclusionCriteria |
| Details |
Patients younger than 18 years of age, pregnant, lactating, and significant medical comorbidities (ASA III or more), history of allergy to LA will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) duration of action
|
1) effect of local anesthesia 4 hours after injection of anesthetic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Pain perception
2) burning sensation on injection |
1) during procedure, number of NSAIDs used after procedure.
2) During injection of local anesthetic |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
21/05/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess the effect of combination of lignocaine (1:200000) and magnesium sulphate on - 3) Burning sensation on injection
Several additives have been combined with local anaesthetics to improve block quality and post-operative analgesia. Magnesium sulphate is one potential additive. Based on previous clinical trials, magnesium sulphate has promising results and has been known to increase the duration of blocks. This additive, if successful can also decrease the number of injections required to achieve clinical levels of local anesthesia. Patients with mandibular impacted third molars requiring trans-alveolar extraction on both right and left side (bilateral extraction). The left side of the patient will be considered as the control site where only lignocaine (1,200,000) will be injected whereas the right side will act as the test side where lignocaine(1:200,000) with magnesium sulphate will be injected.
|