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Comparing 4% Articaine with and without Buffer for Dental Injections in Children: A Split-Mouth Study

Comparative Evaluation of 4% Articaine with and without Buffer for Buccal Infiltration in Children Aged 5 10 Years: A Randomized Split-Mouth Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088503
Enrollment
30
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: 4% Articaine with Buffer: 4% Articaine solution buffered with 8.4% sodium bicarbonate, administered via buccal infiltration Dose:4% Articaine, 0.5 1.0 mL per buccal infiltration site F

Sponsors

I.T.S Centre for Dental Studies and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 5-10 years old children having parental consent for bilateral treatment requiring pulp therapy. 2. Patient with cooperative behaviour, i.e., Frankl behaviour rating positive (+) and definitely positive (++). 3. Patient with no recent history of administration of analgesics.

Exclusion criteria

Exclusion criteria: 1. Children who have history of allergy to any constituents of local anesthesia. 2. Children having abscess/ trauma in relation to the site clinically. 3. Children with any systemic diseases like cardiovascular or thyroid disorders, physically or medically compromised children or where local anesthesia is contraindicated. 4. Patient with uncooperative behaviour, i.e. , Frankl behaviour rating negative (-) and definitely negative (--).

Design outcomes

Primary

MeasureTime frame
pain on administration - SEM SCALE, WONG BAKER FACES SCALE ONSET OF ANESTHESIA - GINGIVAL PROBING DEPTH OF ANESTHESIA- PIN PRICK METHOD REVERSAL OF ANESTHESIA- STAR QUESSTIONAIRE AND FABTimepoint: Pain on administration - immediately after administration salivary sodium potassium levels- before and after administration onset of anesthesia - every 15 seconds reversal every 15 mins

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Kalash Gupta

I.T.S Centre for Dental Studies and Research

shivanimathur.dr@gmail.com8826221676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026