CTRI Number |
CTRI/2022/07/044039 [Registered on: 15/07/2022] Trial Registered Prospectively |
Last Modified On: |
14/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Dentistry |
Study Design |
Other |
Public Title of Study
|
A clinical study to determine the effectiveness of 2% lignocaine with varying concentration of adrenaline used in dental extraction procedures. |
Scientific Title of Study
|
Comparison of Anaesthetic Efficacy of 2% Plain Lignocaine and 2% Lignocaine with 1:400000 Adrenaline to 2% Lignocaine with 1:200000 Adrenaline in Dental Extraction Procedures – A Randomized Controlled Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Namrata Patil |
Designation |
I MDS ( Oral and maxillofacial surgery) |
Affiliation |
Nair Hospital Dental College |
Address |
Nair Hospital Dental College
Mumbai Central 400008 Nair Hospital Dental College
Mumbai Central 400008 Mumbai MAHARASHTRA 400008 India |
Phone |
9867277017 |
Fax |
|
Email |
drnamratapatil10@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mohan Deshpande |
Designation |
Assistant professor ( Oral and maxillofacial surgery) |
Affiliation |
Nair Hospital Dental College |
Address |
Nair Hospital Dental College
Mumbai Central 400008 Nair Hospital Dental College
Mumbai Central 400008 Mumbai MAHARASHTRA 400008 India |
Phone |
9867277017 |
Fax |
|
Email |
mddomfs1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Namrata Patil |
Designation |
I MDS ( Oral and maxillofacial surgery) |
Affiliation |
Nair Hospital Dental College |
Address |
Nair Hospital Dental College
Mumbai Central 400008 Nair Hospital Dental College
Mumbai Central 400008 Mumbai MAHARASHTRA 400008 India |
Phone |
9867277017 |
Fax |
|
Email |
drnamratapatil10@gmail.com |
|
Source of Monetary or Material Support
|
Department of Oral and Maxillofacial Surgery. Nair Hospital Dental College. Mumbai 400008 |
|
Primary Sponsor
|
Name |
Self Dr Namrata Patil |
Address |
Samodiya apartments, hanuman road, powai, Mumbai |
Type of Sponsor |
Other [Self financed] |
|
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 Namrata Patil |
Department of Oral and Maxillofacial Surgery (1st floor)Nair Hospital Dental College |
Mumbai Central Mumbai MAHARASHTRA |
9867277017
drnamratapatil10@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Nair Hospital Dental College Institutional Ethics Committe |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
2% lignocaine |
A total of 25 patients will receive upto 4ml of anesthetic solution once. |
Intervention |
2% lignocaine With 1: 2 lakh adrenaline subperiosteal injection. |
A total of 25 patients will receive upto 4 mls anesthetic solution once. |
Intervention |
2% lignocaine With 1:4 lakh adrenaline subperiosteal injection |
A total of 25 patients will receive upto 4 mls anesthetic solution once. |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Individuals falling in 40-60 age group.
individuals needing maxillary molar/premolar extractions.
Individuals with controlled hypertension.
|
|
ExclusionCriteria |
Details |
Individuals with known H/O of thyroid disorder, renal disease , uncontrolled hypertension ,under antiplatelets & anticoagulant therapy , bronchial asthma and pregnant females
Patients with known allergy to any of the study drugs.
Mentally challenged patients.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Pain measured by Visual Analog Scale |
5 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
Need for suturing |
yes/no |
Blood pressure |
Mm of Hg by automated sphygmomanometer before and after LA injection and immediately after completion of the extraction procedure. |
Volume of anesthetic agent |
ml |
Pulse |
Beats per minute before and after injection of local anesthetic and immediately after extraction procedure |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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/ Phase 3 |
Date of First Enrollment (India)
|
18/07/2022 |
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
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Local anaesthetics are used to carry out minor surgical procedures in dentistry. They ensure a painless procedure especially during manipulation of mucosa and bone and thereby proved to minimize anxiety in patients. Vasoconstrictors are added to improve the efficiency of the local anaesthetic agent by reducing the rate of absorption from the site of administration thereby minimizing toxicity and prolonging the duration of action. It also reduces haemorrhage thus ensuring a bloodless field for the procedure. Advent of adrenalized local anaesthesia solutions and their ease of administration have enabled the surgeon to perform minor surgeries on a walk in and walk out basis for needy patients and for those patients unfit for general anaesthesia. Systemically adrenaline like vasoconstrictors are known to trigger cardiovascular disturbances. These range from tachycardia and raised blood pressure to ventricular fibrillation, myocardial infarction and cerebrovascular accidents. While most are short lived due to rapid absorption and metabolism of adrenaline, the potential risk of serious outcomes increases the chance of threat to life of the patient. Due to the risk of these occurrences adrenalized local anaesthetics are contraindicated for use by cardiologists in patients with known history of hypertension or cardiac disease. However, plain local anaesthesia solutions suffer from the problem of inadequate depth and duration of anaesthesia. This leads to increased endogenous catecholamine release due to the anxiety and fear experienced by the patient secondary to the pain felt at the surgical site thus increasing the potential risk for cardio/cerebrovascular events. In present times due to various factors such as increased stress faced in daily life, the younger population in the 4th decade of life has a significant number of silent members with cardiac disease such as hypertension and coronary insufficiency. Use of adrenalized LA agents in such subjects with silent cardiac disease during dental procedures may therefore prove to be risky to the patient and invite medico-legal action against the surgeon. In view of the increasing incidence of silent cardiac disease in younger population as well as increase in number of senior citizens with known cardiac disease seeking dental surgery this study is proposed to find a golden mean with respect to the safe concentration of adrenaline from the view point of maintaining the efficacy of local anaesthetic without increasing the risk potential to patients with covert/overt cardiac disease. At present 2% lignocaine HCL combined with adrenaline in a concentration of 1: 200000 is the most widely used local anaesthetic solution for dental procedure. Patient comfort during extraction and endodontic therapy remain the gold standard for measuring of the local anaesthetic efficacy. In this study it is proposed to compare the efficacy of 2% plain lignocaine with 2% lignocaine combined with adrenaline 1:400000 to 2% lignocaine combined with 1:200000 as the standard (control) solution. The efficacy will be tested on willing patients needing a maxillary molar/premolar extraction in the cardiac risk prone age group of 40-60 years. Pre and post injection blood pressure and pulse will be used as parameters to monitor the haemodynamic changes. Post extraction bleeding will be recorded 30 minutes after the extraction procedure to evaluate the need for suturing for control of post operative bleeding following extraction in all three groups. |