| CTRI Number |
CTRI/2026/01/102431 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 4 percent articaine infiltration and 2 percent lignocaine nerve block for anesthesia in DMH-affected primary second molars: A split-mouth randomized controlled trial. |
|
Scientific Title of Study
|
Comparative clinical efficacy of 4 percent articaine infiltration versus 2 percent lignocaine IANB block for anesthiesia of DMH-affected primary second molar - Split mouth Randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Chandak |
| Designation |
post graduate student |
| Affiliation |
Saveetha Dental College and Hospital. |
| Address |
saveetha dental college and hospital
162, Poonamallee High Road,
Velappanchavadi, Chennai,
Tamil Nadu 600 077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rasika Chandak |
| Designation |
post graduate student |
| Affiliation |
Saveetha Dental College and Hospital. |
| Address |
saveetha dental college and hospital
162, Poonamallee High Road,
Velappanchavadi, Chennai,
Tamil Nadu 600 077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Rasika Chandak |
| Designation |
post graduate student |
| Affiliation |
Saveetha Dental College and Hospital. |
| Address |
saveetha dental college and hospital
162, Poonamallee High Road,
Velappanchavadi, Chennai,
Tamil Nadu 600 077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college ,Poonamallee high road , chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college |
| Address |
162, Poonamallee High Road,
Velappanchavadi, Chennai,
Tamil Nadu 600 077, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rasika Chandak |
Saveetha dental college and Hospital |
162, Poonamallee High Road,
Velappanchavadi, Chennai,
Tamil Nadu 600 077, India
Thiruvallur
TAMIL NADU |
7038376379
152411004.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine (Lidocaine) with 1:100,000 adrenaline — Inferior Alveolar Nerve Block (IANB) |
Formulation: 2% lignocaine hydrochloride with adrenaline 1:100,000.
Route: Injection — inferior alveolar nerve block (standard Halstead technique or operator’s standard IANB technique).
Dose/Volume per injection: Typically 1.5–2.0 mL for IANB (adjusted by clinician according to patient weight and age), ensuring total dose does not exceed the recommended maximum (use mg/kg guidelines).
Needle/Equipment: Disposable 27G or 25G dental syringe/needle and standard aspiration-capable dental syringe.
Timing: Single administration on the appointment side; in split-mouth design the contralateral appointment will receive the alternative intervention.
Onset & assessment: Record onset time (time to subjective numbness) and test objective anesthesia (cold/pressure/pulp testing or standardized pain scale) before proceeding with the dental procedure.
Monitoring & safety: Monitor patient for signs of systemic toxicity, allergic reaction, or inadequate anesthesia. Resuscitation equipment and emergency drugs should be available.
Rescue plan: If inadequate anesthesia, allow a single supplemental injection (e.g., buccal infiltration with same agent or repeat IANB) — document and classify as failure/supplemented per protocol.
Contraindications: Known allergy to amide local anesthetics or adrenaline; relative caution in uncontrolled hyperthyroidism, certain cardiac conditions — screen per standard dental pre-op protocol.
Rationale for comparator use: 2% lignocaine IANB is a widely used standard-of-care technique for mandibular molar anesthesia, allowing direct comparison to infiltration with articaine in DMH-affected second primary molars. |
| Intervention |
4% Articaine Infiltration |
Group A (Test): 4% articaine with 1:100,000 adrenaline will be administered via buccal infiltration at the DMH affected second primary molar site.
Group B (Control): 2% lignocaine with 1:100,000 adrenaline will be administered using the standard inferior alveolar nerve block technique.
Both interventions will be performed in a split-mouth randomized controlled trial design, where each patient will receive both types of anesthesia on contralateral sides in different appointments.
The anesthetic efficacy will be evaluated clinically before and during restorative, pulpectomy or extraction procedures.
Dosage: Standard recommended dosage for pediatric patients will be followed, not exceeding the maximum safe dose.
Duration: Single administration per side during each appointment.
Route of administration: Injection (local anesthesia). |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4 to 8 years requiring dental treatment for bilateral DMH-affected primary second molars in the mandible.
Children diagnosed with dentin hypersensitivity/dentin mineralization hypoplasia (DMH) involving primary second molars, confirmed clinically and radiographically.
Teeth indicated for restorative treatment or pulpal therapy requiring local anesthesia.
Children classified as ASA Physical Status I or II.
Children exhibiting positive or definitely positive behavior (Frankl Behavior Rating Scale).
Availability of bilaterally comparable teeth, allowing a split-mouth study design.
Children whose parents or legal guardians provide written informed consent, with assent obtained from the child where appropriate. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Children with a known allergy or hypersensitivity to articaine, lignocaine, or amide local anesthetics.
Children with systemic diseases, bleeding disorders, or neurological conditions that contraindicate local anesthesia administration.
Children with acute dental infection, abscess, cellulitis, or swelling in the region of the involved teeth.
Teeth with advanced pathological root resorption, periapical pathology, or mobility exceeding physiological limits.
Children who had received analgesics, sedatives, or local anesthesia within 24 hours prior to the dental procedure.
Children with negative behavior (Frankl Rating I or II) that could compromise the administration or assessment of local anesthesia.
Children with a history of failed mandibular nerve block or anatomical abnormalities affecting nerve block efficacy.
Children with special healthcare needs that could interfere with pain perception, communication, or cooperation during treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anesthetic Success Rate
Assessed by the absence of pain during the dental procedure on the DMH-affected primary second molar following administration of the assigned anesthetic technique (4% articaine infiltration or 2% lignocaine inferior alveolar nerve block).
Pain will be evaluated using an age-appropriate validated pain scale (e.g., Wong–Baker FACES Pain Rating Scale) at the time of operative intervention. |
0 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2027 |
| 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="0"
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 split-mouth randomized controlled trial aims to compare the clinical efficacy of 4% articaine administered by buccal infiltration with 2% lignocaine administered through inferior alveolar nerve block (IANB) for achieving local anesthesia in DMH-affected primary second molars in children. Each participant will receive both anesthetic techniques on contralateral sides during separate appointments. The primary outcome will be the success of anesthesia as assessed by pain experienced during dental treatment. Secondary outcomes will include onset and duration of anesthesia, pain during injection, need for supplemental anesthesia, child behavior, and the occurrence of any adverse events. The findings of this study will help determine the most effective and child-friendly anesthetic technique for managing dental procedures in DMH-affected primary molars. |