| CTRI Number |
CTRI/2025/07/090804 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effectiveness of ropivacaine with dexamethasone for pain after wisdom tooth removal |
|
Scientific Title of Study
|
Evaluation of efficacy of Ropivacaine hydrochloride with Dexamethasone in third molar surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUKMINI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Room number 2,Department of Oral and Maxillofacial Surgery
Ragas Dental College and Hospital
2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119
Chennai
TAMIL NADU
600119
India |
| Phone |
9750374581 |
| Fax |
|
| Email |
srukmini493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B.VIKRAMAN |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Room number 2,Department of Oral and Maxillofacial Surgery
Ragas Dental College and Hospital
2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119
Chennai
TAMIL NADU
600119
India |
| Phone |
9750374581 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.B.Vikraman |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Room number 2,Department of Oral and Maxillofacial Surgery
Ragas Dental College and Hospital
2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119
Chennai
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 2,Department of Oral and Maxillofacial Surgery
Ragas Dental College and Hospital2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119 |
|
|
Primary Sponsor
|
| Name |
RUKMINI |
| Address |
Room number 2,Department of Oral and Maxillofacial Surgery
Ragas Dental College and Hospital
2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119 |
| 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 |
| DrRUKMINI |
RAGAS DENTAL COLLEGE AND HOSPITAL |
Room number2,Department of Oral and Maxillofacial Surgery,
2/102,EAST COAST ROAD,UTHANDI,
Chennai-600119
Chennai
TAMIL NADU |
9750374581
srukmini493@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Ragas Dental College and Hospital Uthandi, Chennai -119 Tam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENTS UNDERGOING BILATERAL WISDOM TOOTH REMOVAL |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.75% ROPIVACAINE WITH 4mg DEXAMETHASONE |
o.75% Ropivacaine with 4mg dexamethasone is given as inferior alveolar nerve block for wisdom tooth removal |
| Comparator Agent |
2% LIDOCAINE WITH 4mg DEXAMETHASONE |
2% Lidocaine with 4mg Dexamethasone is given as inferior alveolar nerve block for wisdom tooth removal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)all patients who desire surgical extraction of non infected bilaterally impacted lower third molar
2)age group above 18 years
3)both sexes should be included
4)patients with no presenting acute systemic illness such as fever, common cold
5)patients who agree to enroll in the study
6)be available for follow up examinations
|
|
| ExclusionCriteria |
| Details |
1)a history of systemic diseases that contraindicate surgical intervention
2)compromised health conditions,which would affect wound healing
3)acute infection in the surgical site
4)documented allergy to any materials utilised in the study
5)opting out of participating in the study
6)patient with a history of psychiatric disorder
7)pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)duration of soft tissue anesthesia
2)pain
3)swelling
4)mouth opening |
intra operatively, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)SWELLING
2)MOUTH OPENING
3)PAIN |
POSTOPERATIVE DAYS 3,5,7 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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
|
This is a spilt mouth study done in patients with bilaterally impacted mandibular third molars by administrating 0.75% Ropivacine with 4mg Dexamtheasone and 2%Lidocaine with 4mg Dexamethasone to assess its efficacy for duration of soft tissue anesthesia, pain, swelling and mouth opening on postoperative days 3,5 and 7. |