Effects of Topical Anesthetics on Pain and Anxiety in Children

NCT07733622 | Not Yet Recruiting

• 1 other identifier: 2026/300
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dental Anxiety; Children

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  During local anesthetic administration (T1)

Secondary Outcomes (4)

• Heart Rate

  Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)

• Blood Pressure

  Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)

• Peripheral Oxygen Saturation (SpO₂)

  Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)

• Body Temperature

  Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)

Study Arms (4)

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.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Officials

• dilara nil günaçar

  Recep Tayyip Erdoğan University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dilara nil günaçar

CONTACT

+905412940104; dilaranil.tomrukcu@erdogan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share