Dental AnxietyNCT07733622
Effects of Topical Anesthetics on Pain and Anxiety in Children
An observational study of Dental Anxiety and Children, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Children
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 10 Sep 2026
- Phase
- Observational
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of healthy children aged 6-8 years who attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry for routine dental treatment and require maxillary infiltration anesthesia for treatment of a maxillary second primary molar. Only children meeting the eligibility criteria and whose parents or legal guardians provide written informed consent will be enrolled.
Who may be able to join
- Children aged 6 to 8 years.
- Frankl Behavior Rating Scale score of 3 or 4.
- No previous history of local anesthetic injection for dental treatment.
- Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar.
- Requiring non-emergency, painless dental treatment.
- Medically healthy children with no chronic systemic disease, mental disability, or physical disability.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Frankl Behavior Rating Scale score of 1 or 2.
- Physical or intellectual disability.
- History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis.
- Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations.
- Emergency dental treatment or presence of dental pain requiring urgent intervention.
- Chronic liver or kidney disease.
- History of methemoglobinemia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited.
This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes.
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.
- Conditions
- Dental Anxiety, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine Spray | Children who received benzocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. | |
| Benzocaine Gel | Children who received benzocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. | |
| Lidocaine Gel | Children who received lidocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. | |
| Lidocaine Spray | Children who received lidocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety Score (MCDASf)
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Scores range from 8 to 40, with higher scores indicating greater dental anxiety.
Measured: Baseline (T0) and immediately after local anesthetic administration (T2)
Pain During Local Anesthetic Administration
Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable).
Measured: Immediately after local anesthetic administration (T2)
Behavioral Response During Local Anesthetic Administration
Behavioral responses will be evaluated using the Sound, Eye, and Motor (SEM) scale during local anesthetic administration. Higher scores indicate greater pain- and anxiety-related behavioral responses.
Measured: During local anesthetic administration (T1)
Secondary outcomes (4)
Heart Rate
Heart rate will be measured to evaluate the physiological response associated with local anesthetic administration.
Measured: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Blood Pressure
Systolic and diastolic blood pressure will be recorded to assess physiological changes associated with local anesthetic administration.
Measured: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation will be measured using pulse oximetry to monitor physiological status during the procedure.
Measured: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Body Temperature
Body temperature will be recorded before, during, and after local anesthetic administration to evaluate physiological changes during treatment.
Measured: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- dilara nil günaçar, Principal investigator, Recep Tayyip Erdoğan University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733622
- Sponsor's protocol ID
- 2026/300
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07733622
- Acronym / sponsor ID
- 2026/300
- Conditions
- Dental Anxiety, Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 29 Jul 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.
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited.
This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes.
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Benzocaine Spray | – | –Children who received benzocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. |
| Benzocaine Gel | – | –Children who received benzocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. |
| Lidocaine Gel | – | –Children who received lidocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. |
| Lidocaine Spray | – | –Children who received lidocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of healthy children aged 6-8 years who attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry for routine dental treatment and require maxillary infiltration anesthesia for treatment of a maxillary second primary molar. Only children meeting the eligibility criteria and whose parents or legal guardians provide written informed consent will be enrolled.
Key inclusion criteria (7 listed)
- Children aged 6 to 8 years.
- Frankl Behavior Rating Scale score of 3 or 4.
- No previous history of local anesthetic injection for dental treatment.
- Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar.
- Requiring non-emergency, painless dental treatment.
Key exclusion criteria (7 listed)
- Frankl Behavior Rating Scale score of 1 or 2.
- Physical or intellectual disability.
- History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis.
- Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations.
- Emergency dental treatment or presence of dental pain requiring urgent intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dental Anxiety Score (MCDASf)
Time frame: Baseline (T0) and immediately after local anesthetic administration (T2)
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Scores range from 8 to 40, with higher scores indicating greater dental anxiety.
Pain During Local Anesthetic Administration
Time frame: Immediately after local anesthetic administration (T2)
Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable).
Behavioral Response During Local Anesthetic Administration
Time frame: During local anesthetic administration (T1)
Behavioral responses will be evaluated using the Sound, Eye, and Motor (SEM) scale during local anesthetic administration. Higher scores indicate greater pain- and anxiety-related behavioral responses.
4 secondary outcomes
Heart Rate
Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Blood Pressure
Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
Body Temperature
Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
dilara nil günaçar principal investigator
Recep Tayyip Erdoğan University Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Children, run by Recep Tayyip Erdogan University Training and Research Hospital.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact dilara nil günaçar (+905412940104, dilaranil.tomrukcu@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Anxiety Score (MCDASf) (time frame: Baseline (T0) and immediately after local anesthetic administration (T2)). The study lists 3 primary outcomes in all. 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 29 Jul 2026.