| CTRI Number |
CTRI/2025/10/096307 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of lidocaine and articaine for numbing the lower jaw in patients with dental infection-related pain. |
|
Scientific Title of Study
|
Comparison of the anesthetic efficacy of lidocaine Vs articaine for IANB in Peripheral sensitization and differential blockade following acute periapical pathology |
| 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 Abhipsha Tikayat Ray |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi ammal dental college and hospital |
| Address |
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Chennai
TAMIL NADU
600095
India |
| Phone |
08847801978 |
| Fax |
|
| Email |
abhipshatikayatray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thomas Zachariah |
| Designation |
Professor |
| Affiliation |
Meenakshi ammal dental college and hospital |
| Address |
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Chennai
TAMIL NADU
600095
India |
| Phone |
9600073639 |
| Fax |
|
| Email |
thomas.zach@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhipsha Tikayat Ray |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi ammal dental college and hospital |
| Address |
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Chennai
TAMIL NADU
600095
India |
| Phone |
08847801978 |
| Fax |
|
| Email |
abhipshatikayatray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India |
|
|
Primary Sponsor
|
| Name |
Dr Abhipsha Tikayat Ray |
| Address |
Meenakshi Ammal Dental College
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095 |
| Type of Sponsor |
Other [Self Fuinded] |
|
|
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 Abhipsha Tikayat Ray |
Meenakshi ammal dental college and hospital |
Meenakshi Ammal Dental College,
Department of Oral and Maxillofacial Surgery, Room number:5,
Alapakkam Main Road, Maduravoyal, Chennai, Tamil Nadu 600095, India
Chennai
TAMIL NADU |
08847801978
abhipshatikayatray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients reporting to department of oral and maxillofacial surgery for regular extraction of carious tooth with periapical pathology |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percent lidocaine with adrenaline (1:100,000) |
This study aimed to compare the anesthetic efficacy of 2 percent lidocaine with adrenaline and 4 percent articaine with adrenaline for inferior alveolar nerve block in patients with acute periapical pathology, focusing on onset time, pulpal sensibility, proprioceptive blockade, and the need for additional anesthesia, particularly in the presence of peripheral sensitization. |
| Intervention |
4% Articaine with 1:10,000 adrenaline |
This study aimed to compare the anesthetic efficacy of 2 percent lidocaine with adrenaline and 4 percent articaine with adrenaline for inferior alveolar nerve block in patients with acute periapical pathology, focusing on onset time, pulpal sensibility, proprioceptive blockade, and the need for additional anesthesia, particularly in the presence of peripheral sensitization. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria were:
Patients who consent to participate in the study.
Patients over 18 years of age
Patients who fall in the category ASA I and II as per the American Society of Anesthesiologists (ASA) classification.
Patients with acutely infected (acute periodontitis/acute periapical abscess) mandibular teeth are indicated for extraction under LA
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria:
Patients who do not consent to be part of the study.
Patients below 18 years of age.
Patient is allergic to those mentioned above local anesthetic agent or their constituents.
Patients with systemic metabolic and comorbid conditions where tooth extraction is contraindicated.
Uncontrolled diabetes and hypertension
Extraction in patients post radiotherapy
End-stage renal disease
Malignant diseases (Leukemia, lymphoma)
Myocardial infarction or stroke in the past 6 months
Extraction of teeth associated with tumors, benign or malignant
Pregnancy (1st and 3rd trimester) patients
Blood dyscrasias: coagulation and other platelet disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We’ll get to know which combination of local anesthetic agent is effective (2% Lidocaine with adrenaline 1:80,000 concentration or 4% Articaine with adrenaline 1:100,000 concentration) in providing adequate anesthesia during IANB in patients with irreversible pulpitis of mandibular teeth with moderate to severe spontaneous pain |
Before local anesthesia administration, patients will rate pain on a Numeric Pain Rating Scale (0-10). Electric pulp testing will precede LA administration, followed by IANB by the same operator. After 3ml IANB, pulp testing will be done after 10 minutes. Time between LA and numbness or anesthesia onset will be recorded. Tenderness on percussion will be checked; if positive, another 3ml IANB will be administered. After anesthesia, the tooth will be extracted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
06/11/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aimed to compare the anesthetic efficacy of 2 percentage lidocaine with adrenaline and 4 percentage articaine with adrenaline for inferior alveolar nerve block in patients with acute periapical pathology focusing on onset time pulpal sensibility proprioceptive blockade and the need for additional anesthesia particularly in the presence of peripheral sensitization. A prospective randomized double blind clinical study will be conducted on 52 patients diagnosed with acute periapical infections requiring mandibular tooth extraction under local anesthesia Patients will be divided into two groups Group A receiving 2 percent lidocaine and Group B receiving 4 percent articaine Pulpal sensitivity will be evaluated using an electric pulp tester before and after inferior alveolar nerve block The time interval between anesthetic administration and onset of subjective and objective signs will be recorded Pain perception will be assessed using a Visual Analog Scale The total anesthetic volume and number of blocks required will be documented |