Not Yet RecruitingNot Applicable

Effects of Topical Anesthetics on Pain and Anxiety in Children

160 participantsStarted 2026-07-30

Plain-language 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 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.

Who can participate

Age range

6 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dental Anxiety Score (MCDASf)

Timeframe: Baseline (T0) and immediately after local anesthetic administration (T2)

Pain During Local Anesthetic Administration

Timeframe: Immediately after local anesthetic administration (T2)

Behavioral Response During Local Anesthetic Administration

Timeframe: During local anesthetic administration (T1)

Trial details

NCT IDNCT07733622

SponsorRecep Tayyip Erdogan University Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

Contact for this trial

dilara nil günaçar

+905412940104 dilaranil.tomrukcu@erdogan.edu.tr

View on ClinicalTrials.gov More Dental Anxiety trials