Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth

NCT04732104 | Completed Early Phase 1 DMC

• 1 other identifier: UWahid
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• Achievement of local anesthesia

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

  First reading on VAS will be taken after administering 2 intranasal sprays i.e. 14 minutes after administration of the first spray

• Achievement of local anesthesia

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

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

Study Arms (2)

intranasal spray anesthesia

EXPERIMENTAL

intranasal lidocaine lidocaine 4% topical

Drug: Lidocaine topical

injectable local anesthesia

ACTIVE COMPARATOR

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

Drug: Lidocaine Hydrochloride

Interventions

Lidocaine topical 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

Also known as: xylometazoline intranasal OTC decongestant

intranasal spray anesthesia

Lidocaine Hydrochloride DRUG

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

Also known as: gold standard local anesthesia

injectable local anesthesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Umair Wahid, MDS

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 1, 2021
• Study Start: July 20, 2018
• Primary Completion: June 30, 2020
• Study Completion: August 14, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)