| CTRI Number |
CTRI/2024/06/068518 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two types of injection on pain, restricted mouth opening and swelling after removal of unerupted lower wisdom teeth |
|
Scientific Title of Study
|
The efficacy of sublingual and intravenous injection of dexamethasone on pain, trismus and swelling after surgical removal of impacted mandibular third molars: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreelekshmi J |
| Designation |
Post Graduate Student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room No:2
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag,
Sullia D K
Karnataka
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8281104947 |
| Fax |
|
| Email |
dr.sreelekshmijayasree@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasanna Kumar D |
| Designation |
Professor and Head of Department |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital,
Kurunjibhag,
Sullia D K
Karnataka
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9448177525 |
| Fax |
|
| Email |
dr_prasanna_74@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasanna Kumar D |
| Designation |
Professor and Head of Department |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital,
Kurunjibhag,
Sullia D K
Karnataka
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9448177525 |
| Fax |
|
| Email |
dr_prasanna_74@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital
Kurunjibhag
Sullia D K
Karnataka
Pincode - 574327 |
|
|
Primary Sponsor
|
| Name |
Dr. Sreelekshmi J |
| Address |
KVG Dental College and Hospital,
Kurunjibhag,
Sullia D K,
Karnataka-574327 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sreelekshmi J |
KVG Dental College and Hospital |
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag
Sullia D K Dakshina Kannada KARNATAKA |
8281104947
dr.sreelekshmijayasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted mandibular third molars which requires surgical removal by the guttering method. |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Intravenous injection of 2ml Dexamethasone preoperatively within a time duration of 2 minutes |
| Intervention |
Dexamethasone |
Sublingual injection of 2ml Dexamethasone preoperatively
within a time duration of 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with impacted lower third molars symmetrically placed on mandible, which requires surgical removal by flap reflection, bone guttering and tooth sectioning.
Healthy patients (ASA I).
Patients who are willing to take part in study. |
|
| ExclusionCriteria |
| Details |
1.Patients on long-term steroids.
2.Pregnant and lactating women.
3.Patients with acute infection and trismus.
4.Patient allergic to local anesthetics and other drugs that will be used in this study.
5.Patient with facial deformities that may hinder injections, surgery or evaluation.
6.Patients with cardiovascular problems, renal and/or liver failure, or other severe medical conditions.
7.Not being able to follow instructions or cooperate during study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of dexamethasone administration through intravenous and sublingual routes on pain using VAS scale, Swelling using Schultze-Mosgau method and mouth opening by interincisal measurement in impacted mandibular third molar surgeries |
Postoperative day 1,2,3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any effect on quality of life |
1 week |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
17/06/2024 |
| 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="2" Months="0" 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
|
Various methods of administering dexamethasone in third molar surgery have been proposed. Intravenous (IV) injection requires additional clinical expertise, and administering IV dexamethasone in conscious patients may lead to transient perineal irritation (itching, burning, or squeezing sensation) in some individuals. Additionally, a single IV injection of dexamethasone can spread widely throughout the body, potentially resulting in less than optimal effectiveness at the injury site. The sublingual route has advantage of not causing additional postoperative pain for patients when administered following common dental interventions like the inferior alveolar nerve block, lingual nerve block and long buccal nerve block typically performed in mandibular third molar procedures. This method is straightforward and easily manageable for dentists. In present study, the effectiveness of dexamethasone administered via sublingual versus intravenous routes will be assessed, the outcome of this study will help the dental surgeons to choose the appropriate route of administration of dexamethasone. Under strict aseptic conditions, patients will be prepared for the surgical procedure. A classical inferior alveolar nerve block, along with lingual and long buccal nerve block will be administered. After 5 minutes, patients in Group A will receive 8 mg dexamethasone intravenously injected into either the median cubital or radial vein, whereas, patients in Group B will receive 8 mg injection dexamethasone into sublingual space. Time taken to administer dexamethasone through both the routes will be noted using timer. Utilizing a standard Ward’s incision, access will be gained, and the tooth will be extracted after necessary bone cutting and tooth splitting, ensuring minimal tissue trauma. Post-extraction, the socket will be thoroughly irrigated with a 5% povidone-iodine solution diluted with equal proportion of normal saline. The flap will then be sutured back using two interrupted sutures of 3-0 BBS (Black Braided Silk). Follow-up appointments will be scheduled for all patients on first,second,third and seventh postoperative days. Suture removal will be carried out on the seventh postoperative day if the healing is assessed to be satisfactory. |