Efficacy Of Lidocaine And Xylometazoline Intranasal Spray In Anesthetizing Maxillary Teeth: An Open Label Randomized Controlled Trial

Abstract BACKGROUND: The most commonly used technique to anesthetize maxillary teeth is the infiltration anesthesia that currently is the gold standard. However, infiltration uses a dental needle that is associated with its de merits also. This led to the discovery of novel methods to anesthetize teeth. We in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary teeth for restorative procedures. The most commonly used technique to anesthetize maxillary teeth is the infiltration anesthesia that currently is the gold standard. However, infiltration uses a dental needle that is associated with its de merits also. This led to the discovery of novel methods to anesthetize teeth. We in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary teeth for restorative procedures. A total of 60 patients were enrolled in the study. Thirty patients were randomized each to lidocaine/Xylometazoline or to control local anesthesia group. Group A participants received 4% Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants received injectable local anesthesia. Local anesthesia was then assessed and reading was taken on the Visual Analog Scale. If the reading was ‘0’ the cavity preparation was performed. If the VAS reading was more than ‘0’ a third dose of intranasal spray anesthesia was delivered. If profound local anesthesia was still not achieved the case was labeled as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of conventional infiltration anesthesia. SPSS v.16 was used to analyze the data with level of significance set at p<0.05. Demographic data were analyzed upon the basis of frequency and percentages. Chi-square test and Fischer exact test were applied to see the difference of efficacy among the two groups and any influence of variables on the efficacy. RESULTS: 21 out of 30 (70%) patients from Group A were anesthetized by intranasal spray anesthesia while all 30 (100%) patients from Group B had successful anesthesia by conventional infiltration. The p value computed is <0.05. No statistically significant effects of age group, gender, tooth location or the number of sprays was observed on the efficacy of intranasal spray anesthesia (p>0.05). There was a statistically significant effect of ICDAS score on the efficacy of intranasal spray anesthesia (p<0.05). CONCLUSION: Lidocaine xylometazoline intranasal spray solution was fairly efficacious in anesthetizing maxillary teeth with smaller carious lesions for restorative procedures in patients with a stable medical history. Intranasal spray solution can be used for patients with needle phobia.TRIAL REGISTRATION: The study is registered on clinical trials website via NCT04732104 on 26/01/2021.