| CTRI Number |
CTRI/2025/07/090619 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of efficacy of 4 percentage Articaine when administered for non-surgical extraction of mandibular third molar |
|
Scientific Title of Study
|
Evaluation of efficacy of 4 percentage Articaine with 1:100000 epinephrine when administered as inferior alveolar nerve block and long buccal nerve block for non-surgical extraction of mandibular third molar |
| 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 SINDHUJA S |
| Designation |
Postgraduate student |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery,
Ragas Dental College and Hospital,
2/102, East Coast Road, Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9677423958 |
| Fax |
|
| Email |
drsindhuja2511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIKRAMAN B |
| Designation |
Head of the Department |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery,
Ragas Dental College and Hospital,
2/102, East Coast Road, Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIKRAMAN B |
| Designation |
Head of the Department |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery,
Ragas Dental College and Hospital,
2/102, East Coast Road, Uthandi,
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ragas Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr SINDHUJA S |
| Address |
Postgraduate student,
Department of Oral and Maxillofacial Sugery,
Ragas Dental College and Hopital,
2/102, East Coast Road, Uthandi,
Chennai |
| 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 SINDHUJA S |
Ragas Dental College and Hospital |
Department of Oral and Maxillofacial surgery,
Ragas Dental College and Hospital,
2/102, East Coast Road, Uthandi,
Chennai
Chennai
TAMIL NADU |
9677423958
drsindhuja2511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ragas Dental College and Hospital, Uthandi, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries in mandibular third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
4% Articaine |
To evaluate efficacy of 4 percentage Articaine when used as local anesthetic agent for non-surgical extraction of mandibular third molars |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers between 18 & 60 years of age, who require extraction of lower 3rd molar.
2. Both male and female.
3. Be available for follow up examinations.
4. Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Involvement or proximity of 3rd molar to inferior alveolar nerve using radiographic evaluation (intraoral periapical radiograph/OPG)
2. Impacted teeth.
3. Root canal treated teeth.
4. Allergy to local anaesthetics.
5. Swelling or infection associated with the 3rd molar site.
6. Pregnancy or current lactation.
7. Patients with existing systemic problem.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset, Duration, Intra-operative pain assessment |
On the day of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/08/2025 |
| 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="3"
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
|
In this study 4% Articaine with 1:1,00,000 epinephrine is used as the local anesthetic agent in non-surgical extraction on mandibular third molars. The third molars are not in close proximity to the nerve and is not associated with any periapical pathology. Onset, Duration and Intra-operative pain assessment is recorded on the day of the surgery. Paresthesia is checked using clinical neurosensory tests on the post-operative days 1,3, and 5. |