Dental anxiety
Conditions
Interventions
A parallel, single-blind randomized clinical trial will be conducted with 70 volunteers allocated into two groups of 35 participants each. Participant randomization will be performed using a stratifie
Sponsors
Universidade Federal do Pará
Universidade Federal do Pará
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 to 60 years; good general health status, with no medical contraindications to the administration of local anesthetics; indication for dental procedures requiring local anesthetic infiltration in the oral mucosa of the upper premolar region; prior dental experience related to the administration of local anesthesia in the oral mucosa; no use of analgesic medication within the 24 hours preceding the procedure; absence of pregnancy
Exclusion criteria
Exclusion criteria: Uncooperative behavior during the clinical procedure or data collection; presence of systemic conditions, including diabetes mellitus and arterial hypertension; history of allergic reaction to topical anesthetics; failure to meet the inclusion criteria established by the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: to evaluate the efficacy of 10% Lidocaine spray compared to 20% Benzocaine gel in reducing pain induced by needle insertion and anesthetic injection into the maxillary oral mucosa, assessed by means of the Numerical Rating Scale, based on the comparison of scores obtained from 70 volunteers equally allocated into two groups;Primary outcome finding: comparable efficacy was observed between the topical anesthetics in overall pain reduction, as assessed by the Numerical Rating Scale, with no statistically significant differences between groups in pain perception during needle insertion p = 0.271, aspiration sensation p = 0.136, or anesthetic solution infiltration p = 0.564 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: to quantify the level of pain and discomfort specifically during needle insertion into the oral mucosa, assessed by means of the Numerical Rating Scale, with the aim of identifying potential clinical comfort advantages between the tested agents;Secondary outcome finding: a statistically significant difference was observed in pain perception during needle insertion, as assessed by the Numerical Rating Scale, with significantly higher scores in the Benzocaine group compared to the Lidocaine group p = 0.041, with an effect size classified as moderate;Tertiary outcome: to investigate the relationship between anxiety levels and pain perception during dental treatment, assessed by means of the State-Trait Anxiety Inventory and the Numerical Rating Scale, through statistical correlation analysis of the obtained scores;Tertiary outcome finding: no significant influence of anxiety scores on pain perception or vital signs was observed, as determined by statistical analysis p > 0.05, despite the majority of volunteers presenting scores consistent with high anxiety levels;Quaternary outcome: to monitor the physiological stability of volunteers during the clinical procedure, assessed by means of a sphygmomanometer and a pulse oximeter, through the collection of blood pressure, oxygen saturation, and heart rate data;Quaternary outcome finding: physiological stability of blood pressure, oxygen saturation, and heart rate was observed across measurements taken before, during, and after the procedure, with no statistically significant changes associated with pain or anxiety variables p > 0.05 | — |
Countries
BR
Contacts
Public ContactWilkelly De Lima
Universidade Federal do Pará
Outcome results
None listed