Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04732104
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.
Study:
NCT04732104
Study Brief:
Protocol Section:
NCT04732104