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CTRI Number  CTRI/2024/10/074647 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of 2% Lignocaine, 4% Tetracaine, and Ice for Topical Anesthesia in Greater Palatine Nerve Block: A Randomized Controlled Trial 
Scientific Title of Study   Comparing the Effectiveness of 2% Lignocaine, 4% Tetracaine, and Ice as Topical Anesthesia for Greater Palatine Nerve Block: A Three-Arm Randomized Controlled 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 Shallu Bansal 
Designation  Professor and Head 
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shallu Bansal 
Designation  Professor and Head 
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001


RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shallu Bansal 
Designation  Professor and Head 
Affiliation  Geetanjali Dental and Research Insitute 
Address  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001


RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@gmail.com  
 
Source of Monetary or Material Support  
Geetanjali Dental & Research Institute 
 
Primary Sponsor  
Name  Geetanjali Dental & Research Institute 
Address  Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shallu Bansal  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute, Udaipur  Department of Oral & Maxillofacial Surgery Geetanjali Dental & Research Institute MANAVA KHEDA, GEETANJALI UNIVERSITY, GEETANJALI MEDICITY, NH8 GIRWA, UDAIPUR, Udaipur, Rajasthan, 313001
Udaipur
RAJASTHAN 
9116155666

drshallu23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human research ethic committee of Geetanjali university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  4% Tetracaine, and Ice as Topical Anesthesia for Greater Palatine Nerve Block  here we are using 4% Tetracaine, and Ice as Topical Anesthesia prior to Greater Palatine Nerve Block to check the needle prick sting 
Comparator Agent  2% Lignocaine Topical Anesthesia for Greater Palatine Nerve Block  here we evaluating and comparing the efficacy of 2% Lignocaine, 4% Tetracaine, and Ice as Topical Anesthesia application prior to Greater Palatine Nerve Block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients between age of 18-75 years of both genders.
2.Patients undergoing maxillary posterior teeth extractions.
3.Patients falling under ASA I and ASA II classification.
4.Subjects able and willing to provide well informed written consent and comply with study procedure.
 
 
ExclusionCriteria 
Details  1.Patients receiving pre-op analgesia and sedation.
2.Patients in whom more than one attempt required to secure a successful nerve block.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain at the time of needle prick
2) SEM scale 
intraoperative 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   07/10/2024 
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="3"
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  

Despite the advancements in dentistry, the administration of local anaesthesia remains a source of fear and pain for many patients. The discomfort associated with injections is a significant contributor to dental anxiety, causing psychological trauma. Palatal injections, among various intraoral injections, are particularly known for being more painful.

Numerous modalities have been explored in the literature to alleviate the pain induced by needle pricks. These include the application of topical anaesthetic agents, warming and buffering of the anaesthetic solution, adjustment of infiltration flow rates, counter-irritation, vibration or pressure, acupuncture, hypnosis, computer-controlled delivery systems (such as the WAND), and the use of devices like vibrajet, dental vibe, or jet injectors.

While the use of topical anaesthesia is widely favoured to mitigate needle penetration pain, some studies suggest that its impact may be marginally superior to a placebo effect. Conversely, Martin et al.  concluded that the pain intensity experienced by patients is reduced when they are aware that topical anaesthesia has been applied to alleviate pain. Various topical anaesthetic agents are available, with lignocaine being a commonly used amide local anaesthetic. Lignocaine, available in multiple forms like gel, patches, sprays, and solutions, is predominantly used as 2% lignocaine jelly in dentistry.

Tetracaine is an ester derivative of PABA. Its lipid solubility and anesthetic efficacy was elevated by replacing a hydrogen of the p-amino group with a butyl. In fact, tetracaine is 5 to 8 times more efficacious than cocaine and is the most potent among dental topical anesthetics. Products are available in the form of a spray solution or ointment in concentrations ranging from 0.2 to 2.0%. Products with 0.15% concentrations are sold as injectable agents. On the other hand, cryoanesthesia offers an alternative approach to diminish and eliminate pain perception. Cryoanesthesia involves applying ice or refrigerant spray to counter nerve conduction of pain at the injection site. Studies suggest that it is efficient, effective, and cost-effective, also reducing edema, nerve conduction velocities, cellular metabolism, and local blood flow.

While there is substantial evidence in the literature comparing tetracaine with ice or 2% lignocaine with ice, there is a scarcity of literature comparing all three—4% tetracaine, 2% lignocaine, and ice—simultaneously to determine their efficacy in palatine nerve blocks. Therefore, this study aims to compare the efficacy of an ice stick in reducing needle prick pain with 4% tetracaine and 2% lignocaine during the administration of greater palatine nerve blocks.

 
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