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OpenTrials
Completed

NCT Number: NCT07279285

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

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

Completed

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Key information

Conditions

Injection Pain Facial Pain Injection Pain Prevention Local Anesthesia Infiltration Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatric Patients Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lamis

Amman, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children who are 6-12 years of age.
  • Children classified as ASA1 according to the American Society of Anesthesiologists.
  • Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
  • 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).
  • Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.

Exclusion criteria

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

Treatment and study plan

Sugar-free-flavored sweet tasting solution

Other

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

Placebo (sterile-water)

Other

Placebo (sterile water)

Primary outcomes

  1. Self-reported pain using faces pain scale-revised (FPS-r)

    Time frame: Immediately after local anesthetic injection

    Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.

  2. Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale

    Time frame: During administration of the local anesthetic injection

    Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.

  3. Physiological-Heart Rate

    Time frame: Baseline and During Injection

    Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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