| CTRI Number |
CTRI/2025/12/098438 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Pain control during lower wisdom tooth removal using two different local anaesthesia techniques. |
|
Scientific Title of Study
|
A randomized clinical trial comparing the effectiveness of intraligamentary and infiltration anesthesia techniques versus inferior alveolar nerve block using four percent articaine for intraoperative pain management in partially erupted mandibular third molar surgery |
| Trial Acronym |
A-LINE Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afsana Ahmed |
| Designation |
Postgraduate trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600095
India |
| Phone |
07896551329 |
| Fax |
|
| Email |
afsanaahmed9897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P. Anantanarayanan |
| Designation |
Professor, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600095
India |
| Phone |
9840052670 |
| Fax |
|
| Email |
anantparam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Afsana Ahmed |
| Designation |
Postgraduate trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Maduravoyal, Alapakkam main road, Janaki Nagar, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600095
India |
| Phone |
07896551329 |
| Fax |
|
| Email |
afsanaahmed9897@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College and Hospital
Meenakshi Ammal Dental College and Hospital
Address:
Alapakkam Main Road, Maduravoyal,
Chennai – 600095,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Afsana Ahmed |
| Address |
Meenakshi Ammal Dental College and Hospital,
Alapakkam Main Road, Maduravoyal,
Chennai – 600095, Tamil Nadu, India.
|
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 |
| Afsana Ahmed |
Meenakshi Ammal Dental College and Hospital |
Room no 5, Dept of Oral and Maxillofacial Surgery, Maduravoyal, Alapakkam main road, Janaki Nagar
Chennai-600095, Tamil Nadu
India
Chennai
TAMIL NADU |
07896551329
afsanaahmed9897@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inferior alveolar nerve block (IANB) using 4% articaine |
Inferior alveolar nerve block administered using 4% articaine with 1:100,000 adrenaline using a standard dental syringe at the mandibular foramen region. Buccal infiltration may be provided as necessary. This serves as the comparator arm against intraligamentary + infiltration anesthesia.
Administration time: approximately 2 minutes. |
| Intervention |
Intraligamentary + Buccal Infiltration Anesthesia using 4% Articaine |
Intraligamentary anesthesia administered using 4% articaine with 1:100,000 adrenaline at the distal and mesial periodontal ligament space of the mandibular third molar, followed by buccal infiltration of 4% articaine. The technique will be performed using an intraligamentary syringe.
Administration time: approximately 2–3 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with partially erupted mandibular third molars indicated for surgical removal
2.ASA I or II healthy individuals
3.Patients willing to participate and provide informed consent
4.Patients aged 18-40 years |
|
| ExclusionCriteria |
| Details |
1.Patients with acute infections at the surgical site(acute pathology)
2.Known allergy or hypersensitivity to articaine or any local anesthetic.
3.Pregnant or lactating women
4.Patients on anticoagulants or with bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative pain perception measured using a 10-point Visual Analog Scale (VAS). |
Time Points:
Baseline (before anaesthesia),
Immediately after administration of anaesthesia(T1),
During incision(T2),
During bone removal(T3),
During tooth elevation(T4),
Immediately after completion of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset time of anesthesia (in seconds). |
Measured immediately after injection until achievement of soft-tissue numbness (recorded in seconds) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="1"
Months="11"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized clinical trial aims to compare the effectiveness of intraligamentary and infiltration anesthesia with inferior alveolar nerve block using 4 percent articaine for intraoperative pain management during surgical removal of partially erupted mandibular third molars. The primary outcome is intraoperative pain measured using a ten point visual analog scale at different stages of surgery. Secondary outcome include onset time of anesthesia. The study will help determine whether intraligamentary and infiltration anesthesia can be a reliable alternative to the conventional inferior alveolar nerve block technique. |