Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth

• Status: Completed
• Trial end date: 2020-08-14
• Target enrollment: 0
• Participant gender: All

Summary

Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. Recently tetracaine and oxymetazoline were used as local anesthetic agents in the form of an intranasal spray to achieve pulpal anesthesia of maxillary teeth. However tetracaine has its share of demerits, therefore we in our study have used lidocaine with xylometazoline in the form of an intranasal spray to achieve local anesthesia of maxillary anterior and premolar teeth for restorative procedures.

The objective of the study was to evaluate the efficacy of 4% lidocaine and 0.1% xylometazoline intranasal spray solution as compared to injectable 2% lidocaine with 1:100,000 epinephrine solution in anesthetizing maxillary anterior & premolar teeth for dental restorative procedures.

METHODS:

A total of 60 patients were enrolled in the study. Consecutive sampling was done for the study participants who met the inclusion criteria. 30 patients were randomized each to lidocaine/Xylometazoline or 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. Group 'A' participants received two doses of intranasal spray anesthesia four minutes apart. Local anesthesia was then assessed by probing soft tissues adjacent to the tooth 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. Local anesthesia was again assessed after ten minutes. 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. Data were recorded on a designed proforma.

Chi-square test and Fischer exact test were applied to see the difference of efficacy among the two groups and any influence of variables (age group, gender, tooth location, cavity classification, ICDAS score or the number of sprays required to produce local anesthesia) on the efficacy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dow University of Health Sciences
• Treatments: Lidocaine; Nasal Decongestants; Xylometazoline

Criteria

INCLUSION CRITERIA

• Adults aged 18-40 years,

• Patients having a vital maxillary premolar, canine or incisor.

• Patients having Class 1,2,3,4 or 5 restorations (G.V. Black).95

• Patients having heart rate between 55 and 100 beats per min.

• Patients with a seated Systolic blood pressure between 95 and 150 mm Hg and diastolic blood pressure between 60 and 100 mm of Hg. (Although short-term use of topical alpha-2 agonists like xylometazoline has no systemic toxicity and are available as over the counter drugs but long-term abuse has been reported to cause systemic vasoconstriction and cardiovascular complications like hypertensive crisis therefore the cut off limit has been selected for blood pressure).

• Teeth with no radiographic evidence of pulpal or periapical pathosis.

• Patients having ICDAS caries detection score of 4, 5 or 6.

• Patients who fulfilled alcohol sniff test criterion.

EXCLUSION CRITERIA

• Patients with Upper respiratory tract infection.

• Patients with Uncontrolled thyroid disease.

• Patients having a known allergy to any of the components used in the solution.

• Pregnant or breast feeding patients.

• Those patients having 5 or more nosebleeds per month.

• Patients who received any local anesthetic/analgesic within 24 hours of study drug administration.