Effects of Topical Anesthetics on Pain and Anxiety in Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-8
SponsorRecep Tayyip Erdogan University Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 4 trial groupsGroup A: Benzocaine Spray
Group B: Benzocaine Gel
Group C: Lidocaine Gel
Group D: Lidocaine Spray
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0) and immediately after local anesthetic administration (T2)2
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).
Time frame
Immediately after local anesthetic administration (T2)3
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.
Time frame
During local anesthetic administration (T1)Secondary outcomes
1
Heart Rate
Heart rate will be measured to evaluate the physiological response associated with local anesthetic administration.
Time frame
Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)2
Blood Pressure
Systolic and diastolic blood pressure will be recorded to assess physiological changes associated with local anesthetic administration.
Time frame
Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)3
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation will be measured using pulse oximetry to monitor physiological status during the procedure.
Time frame
Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)4
Body Temperature
Body temperature will be recorded before, during, and after local anesthetic administration to evaluate physiological changes during treatment.
Time frame
Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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