| CTRI Number |
CTRI/2024/09/074172 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the efficacy of two modes of administration of dexamethasone which include twin mix LA and submucosal injection in the intraoperative and postoperative outcome during mandibular third molar surgery |
|
Scientific Title of Study
|
Evaluating the Efficacy of Twin Mixed Local Anaesthesia and Local Anaesthesia with Submucosal Dexamethasone Injection in Mandibular Third Molar Surgery – Prospective Comparative Clinical 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 |
Karthiga M |
| Designation |
Postgraduate trainee |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8903208812 |
| Fax |
|
| Email |
umkarthiga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghu K |
| Designation |
Professor |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry.
PONDICHERRY
607403
India |
| Phone |
|
| Fax |
|
| Email |
dr.raghuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthiga M |
| Designation |
POSTGRADUATE TRAINEE |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8903208812 |
| Fax |
|
| Email |
umkarthiga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry. |
|
|
Primary Sponsor
|
| Name |
Karthiga M |
| Address |
Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry. |
| Type of Sponsor |
Other [PI] |
|
|
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 |
| Karthiga M |
Indira Gandhi Institute of Dental Sciences |
Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry.
Pondicherry
PONDICHERRY |
8903208812
umkarthiga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted mandibular third molar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LOCAL ANESTHESIA WITH SUBMUCOSAL DEXAMETHASONE |
1.8ml of 2% lignocaine containing 1:200000 adrenaline as inferior alveolar nerve block and 1ml of 4mg dexamethasone as submucosal injection given proximal to surgical site (surrounding tissue) given once |
| Intervention |
TWIN MIX LOCAL ANESTHESIA |
(1.8ml of 2% lignocaine containing 1:200000 adrenaline + 1 ml of 4mg dexamethasone as a single injection for inferior alveolar nerve block given once |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects above the age of 21 with mesioangular impacted mandibular third molar of Pell & Gregory Class-I, Level A.
Subjects who are in good physical status.
Subjects who could understand and are willing to take part in the study and likely to comply with all study procedures
|
|
| ExclusionCriteria |
| Details |
Refusal to participate in the study.
Pregnancy and lactation.
Patient having systemic disorder like diabetes, hypertension, cardiac or neurological disorder.
Patients with reduced mouth opening (mouth opening above 30mm was considered normal)
Patient with history of drug allergy to lignocaine, dexamethasone, amoxicillin, metronidazole, diclofenac.
Patients with active infection.
Patient under any antibiotics or analgesics coverage.
Patient other than Pell & Gregory Class-I Level A.
Patients with severe oral manifestations of systemic disease.
Psychologic or psychiatric conditions that could influence response to treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTRAOPERATIVE PAIN |
3 HOURS |
| POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING |
3rd day, 7th day |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a prospective clinical trial with computer based randomisation to access pain during injection, onset and duration of analgesia, post operative pain, mouth opening and facial swelling. There is
difference in pain during injection, onset of anaesthesia, duration of analgesia, reduction
of postoperative pain, facial swelling followed by improvement in mouth opening. |