Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242743
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-01
Brief Title:
Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia
Sponsor:
Hams Hamed Abdelrahman
Organization:
Alexandria University
Study Overview
Official Title:
Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia a Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
fear of the discomfort that comes with anesthetic needle insertion For dental local anesthesia needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection
Objective of the study The purpose of this study is to assess the effect of needle bevel on patients perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation
Materials and Methods The study will be a double-blind randomized controlled clinical trial with a parallel design A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic Faculty of Dentistry Alexandria University Egypt Children will be selected with scores 3 or 4 Frankel behavioral rating scale Written consent will be obtained from the legal guardian Participants will be randomly allocated into two groups according to the type of needle bevel that will be used Group I test group will receive inferior alveolar nerve block IANB using a double scalpel blade bevel needle while group II control group will receive IANB using a standard blade bevel needle All the procedures will be videotaped Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory Eye and Motor SEM scale After the respective single injection the needles will be fixed on an object slide and prepared for microscopic examination
Objective of the study The purpose of this study is to assess the effect of needle bevel on patients perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation
Materials and Methods The study will be a double-blind randomized controlled clinical trial with a parallel design A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic Faculty of Dentistry Alexandria University Egypt Children will be selected with scores 3 or 4 Frankel behavioral rating scale Written consent will be obtained from the legal guardian Participants will be randomly allocated into two groups according to the type of needle bevel that will be used Group I test group will receive inferior alveolar nerve block IANB using a double scalpel blade bevel needle while group II control group will receive IANB using a standard blade bevel needle All the procedures will be videotaped Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory Eye and Motor SEM scale After the respective single injection the needles will be fixed on an object slide and prepared for microscopic examination
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None