Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-04-01

Brief Summary

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The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children.

The main question it aims to answer is:

Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores.

Participants will:

Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure

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Detailed Description

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Conditions

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Injection Pain Local Anesthesia Infiltration Pain Injection Pain Prevention Pediatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugar-free-flavored sweet tasting solution Group

Group Type ACTIVE_COMPARATOR

Sugar-free-flavored sweet tasting solution

Intervention Type OTHER

A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections

Placebo Group

Group Type PLACEBO_COMPARATOR

Placebo (sterile-water)

Intervention Type OTHER

Placebo (sterile water)

Interventions

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Sugar-free-flavored sweet tasting solution

A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections

Intervention Type OTHER

Placebo (sterile-water)

Placebo (sterile water)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Children who are 6-12 years of age.
2. Children classified as ASA1 according to the American Society of Anesthesiologists.
3. Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
4. Children who required bilateral local anesthesia infiltration injections on primary or permanent teeth either in the maxilla or mandible for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
5. Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.

Exclusion Criteria

1. Children who had a history of unpleasant experiences in dental settings.
2. Children who had a history of unpleasant experience with local anesthesia injection.
3. The presence of medically or developmentally compromising conditions.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes