Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2025-10-01

Brief Summary

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This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

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Detailed Description

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This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.

The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.

Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).

To evaluate pain and anxiety, the following tools will be used:

Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.

Conditions

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Dental Caries Reversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This randomized, split-mouth clinical trial uses a computerized randomization system (Sealed Envelope) to allocate the two interventions: conventional anesthesia and Dental Anesthesia Injector. For each participant, one side of the mouth will receive local anesthesia via the Dental Anesthesia Injector, while the other side will receive the conventional anesthesia method. The randomization process ensures that the assignment of anesthesia methods to the right or left side is random for each participant. Allocation concealment is maintained by a third party who is not involved in data collection and manages the allocation assignments for each new participant

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dental Anesthesia Injector

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa.

Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector .

Group Type EXPERIMENTAL

Dental Anesthesia Injector

Intervention Type DEVICE

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.

Conventional syringe

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Group Type ACTIVE_COMPARATOR

conventional syringe

Intervention Type OTHER

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Interventions

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Dental Anesthesia Injector

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.

Intervention Type DEVICE

conventional syringe

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* normal healthy patients (ASA I)
* Undergoing the first dental local anesthesia experience
* Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
* Score 3 or 4 of Frankl scale of child behavior

Exclusion Criteria

* Presence of gingivitis, dental abscess, facial trauma/ injury
* Administration of analgesic 48 h before randomization
* Presence of allergy from local anesthesia

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes