Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001710
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-14
Brief Title:
Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars
Status:
COMPLETED
Status Verified Date:
2023-08
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:
To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venhams anxiety and behavioral rating scale
Detailed Description:
One of the most effective ways to control pain during invasive dental procedures is the use of local anesthesia which considers the most painful phase of treatment The idea of receiving an injection is fear-inducing for many individuals both children and adults which can lead patients to avoid dental treatments Although such fears are outside the control of dentists some treatment aspects can be modified to increase patient comfort1
Dental care may be associated with pain which may be intertwined with fear and anxiety especially among children with treatment needs The pain intensity is multiplied by having higher dental anxiety a disability age less than 14 years old and gender female The young patients pain expectations may also add to the situational complexity Consequently dental health care may be perceived as insurmountable problem 2 Administrating an anesthetic agent with a traditional syringe causes discomfort during the puncture and injection stages 3 Incorrect handling of the syringe is a determining factor for pain 4 which is exacerbated due to excessive pressure on the plunger and rapid injection of large volumes of anesthetic solution5
To minimize the painful sensation during local anesthesia other methods can be adopted such as applying topical anesthetics prior to injection 6 using computerized injection systems and using needleless jet injection systems 7 A needleless system includes a spring coupled to an apparatus that generates sufficient Pressure to 8 push the plunger of the ampoule 9and makes the anesthetic solution pass through a micro orifice at high speed
The absence of a needle in a jet injection can result in a more comfortable experience as this eliminates the puncture and injection phases which are considered the most painful steps during traditional anesthesia 3 This difference is important as approximately one in five adults have phobia of dental anesthesia due to fear of injections which leads to interruption of dental treatment 10
Since there are no studies about the efficacy of needleless jet injection systems during pulpotomy of lower second primary molars the aim of this clinical trial was to evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars
Dental care may be associated with pain which may be intertwined with fear and anxiety especially among children with treatment needs The pain intensity is multiplied by having higher dental anxiety a disability age less than 14 years old and gender female The young patients pain expectations may also add to the situational complexity Consequently dental health care may be perceived as insurmountable problem 2 Administrating an anesthetic agent with a traditional syringe causes discomfort during the puncture and injection stages 3 Incorrect handling of the syringe is a determining factor for pain 4 which is exacerbated due to excessive pressure on the plunger and rapid injection of large volumes of anesthetic solution5
To minimize the painful sensation during local anesthesia other methods can be adopted such as applying topical anesthetics prior to injection 6 using computerized injection systems and using needleless jet injection systems 7 A needleless system includes a spring coupled to an apparatus that generates sufficient Pressure to 8 push the plunger of the ampoule 9and makes the anesthetic solution pass through a micro orifice at high speed
The absence of a needle in a jet injection can result in a more comfortable experience as this eliminates the puncture and injection phases which are considered the most painful steps during traditional anesthesia 3 This difference is important as approximately one in five adults have phobia of dental anesthesia due to fear of injections which leads to interruption of dental treatment 10
Since there are no studies about the efficacy of needleless jet injection systems during pulpotomy of lower second primary molars the aim of this clinical trial was to evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars
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