| 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
|
|
|
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
|
|
|
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. |