Pain Levels of Intraosseous vs. Infiltration Injections

Pain Levels of Intraosseous vs. Infiltration Injections in Primary Anterior Teeth of Children Aged 4-6 Years: A Randomized Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250413065311N1

Enrollment

Registered

2025-05-15

Start date

2025-05-24

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Pain Levels of Intraosseous vs. Infiltration Injections.

Interventions

Intervention 1: Control group: Before injection in all groups, 20% benzocaine topical anesthetic gel (ADS, Avant Dental Supply, USA) will be applied to the dried mucosa at the injection site for 2 min

Eligibility

Sex/Gender

All

Age

4 Years to 6 Years

Inclusion criteria

Inclusion criteria: Having two anterior teeth on opposite sides that require dental treatment using local anesthesia, in two separate treatment sessions Physical and mental health Informed consent from parents Cooperative at examination session based on Frankl behavior classification scale (positive and definitely positive) Lack of prior dental experience

Exclusion criteria

Exclusion criteria: Dental abscesses Facial trauma History of hospitalization Use of antibiotics, NSAIDs, or acetaminophen within 24 hours prior to the visit

Design outcomes

Primary

Measure	Time frame
Perceived Pain (Objective). Timepoint: Immediately after the injection. Method of measurement: The child will be asked to select the face that best represents their pain level, and the corresponding score will be recorded.;Perceived Pain (Physiologic). Timepoint: 1) When the child is seated in the dental unit and listening to the dentist's explanation. 2) Every 15 seconds during local anesthesia injection. 3) One minute after injection completion. Method of measurement: Heart Rate: Measured using a fingertip pulse oximeter (Buerer, Germany) on the child's index finger at three different time points.;Perceived Pain (Subjective). Timepoint: During the administration of local anesthesia. Method of measurement: For subjective pain assessment, the Modified Venham Behavior Rating Scale will be used. During the administration of local anesthesia, the child will be recorded on video. To eliminate potential bias, the filming will be conducted in a manner that ensures the observer remains completely unaware of the injection technique.Based on the recorded footage, the observer will evaluate the child's behavioral indicators and assign a score according to the most intense reaction exhibited.	—

Measure

Time frame

Perceived Pain (Objective). Timepoint: Immediately after the injection. Method of measurement: The child will be asked to select the face that best represents their pain level, and the corresponding score will be recorded.;Perceived Pain (Physiologic). Timepoint: 1) When the child is seated in the dental unit and listening to the dentist's explanation. 2) Every 15 seconds during local anesthesia injection. 3) One minute after injection completion. Method of measurement: Heart Rate: Measured using a fingertip pulse oximeter (Buerer, Germany) on the child's index finger at three different time points.;Perceived Pain (Subjective). Timepoint: During the administration of local anesthesia. Method of measurement: For subjective pain assessment, the Modified Venham Behavior Rating Scale will be used. During the administration of local anesthesia, the child will be recorded on video. To eliminate potential bias, the filming will be conducted in a manner that ensures the observer remains completely unaware of the injection technique.Based on the recorded footage, the observer will evaluate the child's behavioral indicators and assign a score according to the most intense reaction exhibited.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSana.MohammadBigdeli

Islamic Azad University

sana.mohammadbigdeli@iau.ir+98 21 8841 5546

Outcome results

None listed

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