| CTRI Number |
CTRI/2021/08/035560 [Registered on: 10/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of addition of steroids to local anesthesia on surgical extraction of impacted lower wisdom tooth. |
|
Scientific Title of Study
|
A comparative evaluation of effect of addition of 8 mg Dexamethasone to 2% Lignocaine
with adrenaline in impacted mandibular third molar surgery: A Split Mouth Randomized double blinded Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poorna P |
| Designation |
post graduate student |
| Affiliation |
Manipal Academy of Higher education |
| Address |
Department of Oral and Maxillofacial Surgery,
Manipal College of Dental Sciences - Mangalore
Lighthouse Hill Road, Hampannakatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09701362020 |
| Fax |
|
| Email |
potharaju.poorna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Premalatha Shetty |
| Designation |
professor and associate dean |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Manipal College of dental sciences, lighthouse hill road, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
premalatha.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrPoorna P |
| Designation |
post graduate student |
| Affiliation |
Manipal Academy of Higher education |
| Address |
Department of Oral and Maxillofacial Surgery,
Manipal College of Dental Sciences,
lighthouse hill road,
hampannakatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09701362020 |
| Fax |
|
| Email |
potharaju.poorna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Mangalore |
|
|
Primary Sponsor
|
| Name |
Poorna P |
| Address |
apt 603, Abhiman Hills, Lighthouse hill road, Mangalore |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrPoorna P |
Manipal College of Dental Sciences, Mangalore |
Dept of Oral and
maxillofacial surgery,
Manipal college of
dental sciences, light
house hill road,
Mangalore
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9701362020
potharaju.poorna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexamethasone |
2 ml of 2% Lignocaine with 1:200000 Adrenaline and 8mg Dexamethasone
in 2ml distilled water |
| Comparator Agent |
distilled water |
2ml of 2% Lignocaine with 1:200000 Adrenaline and 2ml
distilled water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Subjects falling under ASA class 1 & 2.
Subjects requiring surgical extraction of bilateral mandibular third molars in class II position B.
Subjects with no acute inflammation, excessive caries, pain and pathology around the mandibular
third molars
Subjects who have signed the informed consent
|
|
| ExclusionCriteria |
| Details |
Subjects with infection around third molars.
Subjects with peptic ulcer.
Subjects who are pregnant and lactating.
Subject with diabetes mellitus, systemic endocrine disorders, hypertension, kidney diseases, blood clotting disorders, obesity.
Subjects having an allergy to any of the drugs or materials to be used.
Subjects who have used antibiotics in the past 2 weeks.
Subjects who have used NSAIDs in the past 1 week.
Subjects who could not cooperate
Subjects who refused to take part in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the difference in time of onset and duration of local anesthesia.
|
1. baseline
2.2-8 hours after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the difference in pain, swelling, and mouth opening. |
24 hours, 48 hours and 1 week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/11/2022 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Surgical extraction of impacted third molars is a routine minor oral surgical procedure carried out usually under local anesthesia and is associated with postoperative sequelae including swelling, pain, trismus, infection, bleeding, and paraesthesia. Diligent administration of local anesthetic agent will help in achieving pain-free surgical extraction while also reducing the risk of paresthesia and trismus post-operatively. An increased depth and duration of action of local anesthetic agent is desirable to minimize the trauma experienced by the patient intra-operatively and in achieving the pain-free transition from the waning anesthesia to analgesic medication in the post-operative period respectively. The goodness of Bupivacaine being a potent, long-acting local anesthetic with low tissue toxicity is nullified by the undeniable fact that it is the most cardiotoxic of them all, involving both electrical and mechanical structures within the heart. Therefore a need exists to find an alternative to Bupivacaine that has a comparable depth and duration of anesthesia. Studies done in other disciplines of surgery and in vivo studies have shown that using corticosteroids as adjuncts to local anesthetics have increased the duration of their action in supraclavicular brachial plexus block, axillary block; sciatic nerve block in rats, and intercostal nerve block in sheep. Adding corticosteroids would also have the added advantage of reduced swelling, pain, and trismus owing to an attenuated inflammatory response. Sizeable research in similar lines has not been done specifically to Oral and Maxillofacial Surgery. Lignocaine is the gold standard drug of choice for local anesthesia in oral surgery when coupled Dexamethasone forms a drug combination that deserves testing. The current study aims to fill the void of insufficient research and test the effect of Dexamethasone added to Lignocaine with Adrenaline on depth and duration of anesthesia, reduction in swelling, trismus, pain, and improved mouth opening in patients undergoing impacted third molar surgeries. |