Dental AnesthesiaNCT07835191
Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children
A study testing Dental anesthesia in people with Dental Anesthesia and Sweet Taste Perception, run by British University In Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Dental Anesthesia, Sweet Taste Perception, Pain and Anxiety
- What is being tested?
- Dental anesthesia
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group 7-11 years
- Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
- Frankl behavior scale 3 and 4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, British University in Egypt
Cairo, El Sherouk
Nada M Farouk, post graduate student, +21020668262, pg.nada92243007@bue.edu.eg
Ola A Abd El-geleel, Associate Professor, +21006086830, ola@dent.asu.edu.eg
About this study
Official title: Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
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.
- Being tested
- Dental anesthesia
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anesthesiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Precooling group | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Precooling + topical anaesthesia group | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Precooling + sweet tasting solution group | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Precooling + sweet tasting solution + topical anaesthesia | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Sweet tasting solution group | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Sweet tasting solution + topical anaesthesia group | Experimental | Not described Receives: Behavioral: Dental anesthesia |
| Topical anaesthesia group | Active comparator | Not described Receives: Behavioral: Dental anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain Intensity assessed by visual analogue scale
Measured: Immediately after intervention
Secondary outcomes (4)
Phase 1 outcome
The preferred sweet tasting solution based on number of patients
Measured: After intervention
Heart Rate
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection
Measured: 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
Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain.
Measured: During needle injection
Oxygen saturation
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection.
Measured: Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start6 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohammed Farouk, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835191
- Sponsor's protocol ID
- 24-028
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07835191
- Acronym / sponsor ID
- 24-028
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age group 7-11 years
- Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
- Frankl behavior scale 3 and 4
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental anesthesiaThe 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. | Behavioural | Precooling + sweet tasting solution + topical anaesthesia, Precooling + sweet tasting solution group, Precooling + topical anaesthesia group, Precooling group, Sweet tasting solution + topical anaesthesia group, Sweet tasting solution group, Topical anaesthesia group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Immediately after intervention
Pain Intensity assessed by visual analogue scale
4 secondary outcomes
Phase 1 outcome
Time frame: After intervention
Heart Rate
Time frame: 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
Time frame: During needle injection
Oxygen saturation
Time frame: Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental anesthesia in people with Dental Anesthesia and Sweet Taste Perception, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.