Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732104
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2021-01-14
Brief Title:
Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth An Open Label Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 xylometazoline intranasal spray solution as compared to injectable 2 lidocaine with 1100000 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 lidocaineXylometazoline or control local anesthesia group Group A participants received 4 Lidocaine and 01 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
The objective of the study was to evaluate the efficacy of 4 lidocaine and 01 xylometazoline intranasal spray solution as compared to injectable 2 lidocaine with 1100000 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 lidocaineXylometazoline or control local anesthesia group Group A participants received 4 Lidocaine and 01 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 01 xylometazoline intranasal spray solution as compared to injectable 2 lidocaine with 1100000 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 DrIshrat 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 lidocaineXylometazoline or control local anesthesia group Group A participants received 4 Lidocaine and 01 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 p005 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
OBJECTIVES
The objective of the study was to evaluate the efficacy of 4 lidocaine and 01 xylometazoline intranasal spray solution as compared to injectable 2 lidocaine with 1100000 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 DrIshrat 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 lidocaineXylometazoline or control local anesthesia group Group A participants received 4 Lidocaine and 01 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 p005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None