Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth

NCT ID: NCT04732104

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-20
• Study Completion Date: 2020-08-14

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.

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.

SPSS v16 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 (age group, gender, tooth location, cavity classification, ICDAS score or the number of sprays required to produce local anesthesia) on the efficacy.

Conditions

Effect of Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intranasal spray anesthesia

intranasal lidocaine lidocaine 4% topical

Group Type: EXPERIMENTAL

Lidocaine topical

Intervention Type: DRUG

intranasal spray anesthesia will be administered for achieving pulpal local anesthesia of maxillary anterior and premolar teeth. Xylometazoline OTC decongestant will be used to prolong the duration of anesthesia

injectable local anesthesia

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

Group Type: ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type: DRUG

injectable local anesthesia will be administered to achieve pulpal local anesthesia of maxillary anterior and premolar teeth

Interventions

Lidocaine topical

intranasal spray anesthesia will be administered for achieving pulpal local anesthesia of maxillary anterior and premolar teeth. Xylometazoline OTC decongestant will be used to prolong the duration of anesthesia

Intervention Type: DRUG

Lidocaine Hydrochloride

injectable local anesthesia will be administered to achieve pulpal local anesthesia of maxillary anterior and premolar teeth

Intervention Type: DRUG

Other Intervention Names

xylometazoline intranasal OTC decongestant; gold standard local anesthesia

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Umair Wahid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umair Wahid, MDS

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UWahid

Identifier Type: -

Identifier Source: org_study_id