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CompletedNCT07279285Updated May 6, 2026

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

An interventional study of Sugar-free-flavored sweet tasting solution and Placebo (sterile-water) in Injection Pain, Local Anesthesia Infiltration and Pain, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Jordan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Injection Pain
  • Local Anesthesia Infiltration
  • Pain
  • Injection Pain Prevention
  • Pediatric Patients

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Keywords

  • clinical trial
  • sugar-free solution
  • local anesthesia pain
  • dental pain
  • injection pain
  • children dental pain
  • split-mouth
  • sugar-free flavored sweet tasting solution
  • SFSS
  • dental fear reduction
  • dental fear
  • dental anxiety
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 54 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

University of Jordan is the lead sponsor of 131 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children who are 6-12 years of age.
  2. Children classified as ASA1 according to the .
  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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Sugar-free-flavored sweet tasting solution Group

    Other: Sugar-free-flavored sweet tasting solution

  • Placebo comparator
    Placebo Group

    Other: Placebo (sterile-water)

Interventions

  • OtherSugar-free-flavored sweet tasting solution

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

  • OtherPlacebo (sterile-water)

    Placebo (sterile water)

06

What researchers measure

Primary outcomes

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

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

    Time frame: Immediately after local anesthetic injection

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

    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.

    Time frame: During administration of the local anesthetic injection

  3. Physiological-Heart Rate

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

    Time frame: Baseline and During Injection

07

Study locations

1 site
  • Lamis
    Amman, Jordan
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Apr 2026, 3 months.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 3 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Dec 12, 2025
StartActual
Jan 1, 2026
Primary completionActual
Apr 1, 2026
CompletionActual
Apr 1, 2026
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07279285
Responsible party
Lamis D. Rajab (Prof, University of Jordan) — Principal investigator
First posted
Dec 12, 2025
Start date
Jan 1, 2026
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026
Last update
May 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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