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Clinical Trials/NCT04732104
NCT04732104CompletedEarly Phase 1

Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth: An Open Label Randomized Controlled Trial

Dow University of Health Sciences1 site in 1 country60 target enrollmentStarted: July 20, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Achievement of local anesthesia

Study Overview

Brief 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.

Detailed Description

Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth. The most commonly used technique 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 with smaller diameter needles or computerized delivery of local anesthesia. 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.

OBJECTIVES:

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:

This open label randomized controlled trial was performed at the Department of Operative Dentistry, Dr.Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences Karachi between July 2018 and June 2020.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

intranasal spray anesthesia

Experimental

intranasal lidocaine lidocaine 4% topical

Intervention: Lidocaine topical (Drug)

injectable local anesthesia

Active Comparator

gold standard infiltration local anesthesia (2% lidocaine with 1:100,000 epinephrine)

Intervention: Lidocaine Hydrochloride (Drug)

Outcomes

Primary Outcomes

Achievement of local anesthesia

Time Frame: If needed, second reading on VAS will be taken after administering 3 intranasal sprays i.e. 24 minutes after administration of the first spray

local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' before cavity preparation must begin

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Umair Wahid

Principal Investigator

Dow University of Health Sciences

Study Sites (1)

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