Effects of 10% Lidocaine and 20% Benzocaine as topical anesthetics on the oral mucosa: a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
A parallel, single-blind randomized clinical trial evaluated the efficacy of 10% lidocaine spray compared to 20% benzocaine gel in the management of procedural dental pain. Fear of injection is a limiting factor that generates anxiety and may deter patients from seeking treatment, making the refinement of topical anesthesia strategies essential. The study enrolled 70 healthy volunteers requiring local infiltrative anesthesia in the maxillary premolar region. Volunteers were randomly allocated into two experimental groups, and pain perception was assessed by the Numerical Rating Scale at different stages, including needle prick, aspiration, and anesthetic solution infiltration, while anxiety levels were measured using the State-Trait Anxiety Inventory. Statistical analysis demonstrated no significant difference between the agents for the majority of assessed variables. However, regarding the initial needle prick sensation, the lidocaine spray group demonstrated superior comfort performance compared to the benzocaine gel group (p = 0.041). Physiological parameters including blood pressure, oxygen saturation, and heart rate remained stable, with no influence of pain or anxiety variables. In conclusion, both topical anesthetics proved effective and safe for use on the oral mucosa, with lidocaine spray representing an advantageous alternative for reducing sensory awareness of initial tissue penetration
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18Y 至 60Y（—）
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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 stratified block design generated by the Random allocation software, carried out by an independent collaborating researcher who will not be involved in the clinical interventions. Single-blind masking will be applied, in which only the statistician will be unaware of group allocation. Interventions will be administered in a single session, with an estimated duration of approximately 6 minutes. Volunteers in both groups will perform a mouthrinse with 15 milliliters of 0.12% Chlorhexidine for one minute, followed by drying of the area with sterile gauze. The Lidocaine spray group (n = 35) will receive topical application of 10% Lidocaine to the vestibular oral mucosa at the level of the apex of the maxillary premolars, using a sterile cotton roll for 3 minutes, at a dose of 5 sprays (50 milligrams). The Benzocaine gel group (n = 35) will receive topical application of 20% Benzocaine to the same region, using a sterile cotton roll for 3 minutes, at a dose of 2 grams measured with a dosing spoon. Following topical anesthetic application, both groups will receive local infiltrative anesthesia with 1.8 milliliters of 2% Mepivacaine, using a 30-gauge short dental needle, with slow deposition of the solution over approximately 2 minutes. Pain perception will be assessed using the Numerical Rating Scale and anxiety levels will be measured using the State-Trait Anxiety Inventory
干预措施: 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 stratified block design generated by the Random allocation software, carried out by an independent collaborating researcher who will not be involved in the clinical interventions. Single-blind masking will be applied, in which only the statistician will be unaware of group allocation. Interventions will be administered in a single session, with an estimated duration of approximately 6 minutes. Volunteers in both groups will perform a mouthrinse with 15 milliliters of 0.12% Chlorhexidine for one minute, followed by drying of the area with sterile gauze. The Lidocaine spray group (n = 35) will receive topical application of 10% Lidocaine to the vestibular oral mucosa at the level of the apex of the maxillary premolars, using a sterile cotton roll for 3 minutes, at a dose of 5 sprays (50 milligrams). The Benzocaine gel group (n = 35) will receive topical application of 20% Benzocaine to the same region, using a sterile cotton roll for 3 minutes, at a dose of 2 grams measured with a dosing spoon. Following topical anesthetic application, both groups will receive local infiltrative anesthesia with 1.8 milliliters of 2% Mepivacaine, using a 30-gauge short dental needle, with slow deposition of the solution over approximately 2 minutes. Pain perception will be assessed using the Numerical Rating Scale and anxiety levels will be measured using the State-Trait Anxiety Inventory