| CTRI Number |
CTRI/2026/02/103180 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Comparative evaluation of anaesthetic efficacy of 4% Articaine v/s conventional 2% Lignocaine with 1:100,000 adrenaline by giving buccal infiltraion for extraction of maxillary anterior teeth : A split-mouth study |
|
Scientific Title of Study
|
A Comparative evaluation of anaesthetic efficacy of buccal infiltration with 4% Articaine
v/s conventional 2% Lignocaine with 1:100,000 adrenaline for extraction of maxillary anterior teeth : A split-mouth study |
| 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 MANJIRI JIVANRAO NAKADE |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
KLE V.K. Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery,
KLE V.K. Institute of Dental Sciences, Belagavi-590010.
JNMC,Camps,nehru nagar ,belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8329795056 |
| Fax |
|
| Email |
drmanjirinakade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJIRI JIVANRAO NAKADE |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
KLE V.K. Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery,
KLE V.K. Institute of Dental Sciences, Belagavi-590010.
JNMC Camps,nehru nagar ,belgavi
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8329795056 |
| Fax |
|
| Email |
drmanjirinakade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sidramesh Muttagi |
| Designation |
Professor |
| Affiliation |
KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, BELAGAVI |
| Address |
JNMC Camps,nehru nagar ,belgavi
590010
Department Of Oral and Maxillofacial Surgery. no-5, Kle V.K. Institute Of Dental Sciences, Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9880491209 |
| Fax |
|
| Email |
siddumuttagi76@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE V.K. Institute of Dental Sciences,Belgavi |
|
|
Primary Sponsor
|
| Name |
DR MANJIRI JIVANRAO NAKADE |
| Address |
Department of Oral and Maxillofacial Surgery,Kle V K Institute of dental sciences,belgavi-590010 |
| Type of Sponsor |
Other [Seif Funding] |
|
|
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 MANJIRI NAKADE |
KLE V.K. Institute of Dental Sciences,Belgavi |
Department Of Oral And Maxillofacial Surgery, department no-5,2nd floor,Kle V.K. Institute Of Dental Sciences, Belagavi-590010
Belgaum
KARNATAKA |
8329795056
drmanjirinakade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MAXILLARY ANTERIOR TOOTH INCLUDING PREMOLARS WHICH ARE INDICATED FOR EXTRACTION |
| Patients |
, (1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine with Adrenaline |
Injecting the Anesthetic agent (1.2ml) on buccal side alone for tooth indicated for extraction and assessing the need for palatal injection with other primary and secondary outcomes
duration- during the procedure and on the same day after the procedure |
| Intervention |
4% Articaine with adrenaline
|
Injecting the Anesthetic agent (1.2ml) on buccal side alone for tooth indicated for extraction and assessing the need for palatal injection with other primary and secondary outcomes of the study
duration-during the procedure and on the same day after the procedure at interval of 4-6hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patient indicated for extraction of bilateral permanent anterior maxillary tooth Including Premolars(from left premolar to right premolar tooth)
-Symptomatic and firm maxillary anterior tooth indicated for extraction.
-Patients with ASA status I and having normal bleeding & clotting time.
-Patient requiring therapeutic tooth extraction for orthodontic purpose
|
|
| ExclusionCriteria |
| Details |
-Patients allergic to anaesthetic agent
-Patient with periodontally compromised permanent maxillary anterior tooth including premolar (excluding central incisor)
-Patient with systemic co-morbidities .
-Pregnancy
-Lactating female subjects.
-Patients who have any pathologies at the extraction site.( Example: cyst, odontomes., etc)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the anaesthetic efficacy of ‘4% articaine’ and ‘2% lignocaine’ with buccal infiltration in bilateral maxillary tooth indicated for extraction
and Need for palatal Injection to be given |
on the same day during & after the procedure at interval of 4-6hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate onset, duration & depth of anesthesia & peri operative pain assesment |
on the same day during & after the procedure at interval of 4-6hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="6"
Days="15" |
|
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
|
-Effective control of pain during dental procedures has been one of the most important prerequisite of dentistry.Local anesthesia is used to reduce pain while performing the extraction of teeth. -Many patients avoid dental extractions due to painful injection. In the present-day dental practice, Providing treatment with least amount of pain and discomfort is the key. Extraction of maxillary teeth require buccal and palatal infiltration of anesthetic drug And Palatal infiltration is often painful and patients are likely to be uncooperative -Articaine, synthesized in 1975, has been widely used since. In contrast to lignocaine, it has a higher tissue diffusion rate and lower toxicity and it is 1.5times more potent than lignocaine with shortest elimination half-life (42min) making it the currently safest option. -Hence, the current study will be conducted to evaluate the anesthetic efficacy of articaine versus Lignocaine in extraction of maxillary anteriors, the necessity of giving a palatal infiltration in addition to buccal infiltrationbuccal infiltration.
|