NCT07835191

Brief Summary

The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children. It has two phases: Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey. Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations. The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Oct 2025Apr 2027

Study Start

First participant enrolled

October 6, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 7, 2026

Last Update Submit

September 16, 2026

Conditions

Dental AnesthesiaSweet Taste PerceptionPain and AnxietyBehavioral Management

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    Pain Intensity assessed by visual analogue scale

    Immediately after intervention

Secondary Outcomes (4)

  • Phase 1 outcome

    After intervention

  • Heart Rate

    Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection

  • Sound, eye and motor scale (SEM) scale

    During needle injection

  • Oxygen saturation

    Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage

Study Arms (7)

Precooling group

EXPERIMENTAL
Behavioral: Dental anesthesia

Precooling + topical anaesthesia group

EXPERIMENTAL
Behavioral: Dental anesthesia

Precooling + sweet tasting solution group

EXPERIMENTAL
Behavioral: Dental anesthesia

Precooling + sweet tasting solution + topical anaesthesia

EXPERIMENTAL
Behavioral: Dental anesthesia

Sweet tasting solution group

EXPERIMENTAL
Behavioral: Dental anesthesia

Sweet tasting solution + topical anaesthesia group

EXPERIMENTAL
Behavioral: Dental anesthesia

Topical anaesthesia group

ACTIVE COMPARATOR
Behavioral: Dental anesthesia

Interventions

Dental anesthesiaBEHAVIORAL

The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection.

Precooling + sweet tasting solution + topical anaesthesiaPrecooling + sweet tasting solution groupPrecooling + topical anaesthesia groupPrecooling groupSweet tasting solution + topical anaesthesia groupSweet tasting solution groupTopical anaesthesia group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group 7-11 years
  • Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
  • Frankl behavior scale 3 and 4

You may not qualify if:

  • Failure to provide assent or consent
  • Allergy from local anesthetic solution
  • Systemic diseases such as diabetes that could affect pain perception
  • History of abscess or fistula at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, British University in Egypt

Cairo, El Sherouk, Egypt

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Anesthesia, Dental

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 22, 2026

Study Start

October 6, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations

EG(1)