Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541925
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
The Effect of Needle-free Injection System on Dental Injection Pain in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Needle-free Injection System on Dental Injection Pain in Children A Cross-over Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to compare paediatric patients pain perception and behavioural response during dental injection using needle free injection NF or traditional injection method TM over two consecutive visits
Detailed Description:
Pain is a complex and multidimensional construct that involves sensory emotional and cognitive processes One of the most important part of child behaviour guidance is pain control and the most common method used to achieve pain control in dental procedures is using local anestheticsLA Nevertheless administering a LA injection is among the most anxiety-provoking procedure for both children and adults patients in dentistry Knowledge about change in pain related behaviour during consecutive visits helps in and scheduling of treatment procedures and management of children in dental clinic
Thus numerious methods and techniques have been suggested to minimizereduce pain due to infiltration of LA agents including application of topical anesthesia pre-cooling injection site pressure administration to injection site applying laser as pretreatment method warming and buffering the local anesthetics tactile stimulations distraction technique use of narrow needles and slow delivery of the injection solution computerized injection systems employing modern devices such VibraJect DentalVibe or Aculief have been tried out to allay the fears of child patients However none of them gained universal acceptance and more situations and techniques need to be evaluated to improve stress management among patients in dental settings
During the administration of a LA injection an anxious patient might perceive more severe pain of longer duration than would a less anxious patient Visually and psychologyically the dental syringe is perceived as a threatening instrument especially by children Fear of pain from the needle has been frequently indicated to be the most fear-evoking stimulus for dentally anxious children
The needle- free injection system may yield a higher level of comfort because it involves no puncture or injection phase and has emerged as a novel alternative to traditional needle- based techniques The Comfort-inTM system Mika Medical Busan Korea is a recent dental device that uses a needle-free injection technique to administer local anesthesia This system is a patented device using the liquid jet system to inject the anesthetic solution rapidly from a 015-mm hole with high pressure The use of this needle-free local anaesthesia system in dentistry can be of a help in treating needle phobia patients To the extent of investigators knowledge there were few studies have evaluated the effectiveness of this new injection technique on primary molars in children Investigators feel that paediatric patients are the target group for whom pain control should be adequately followed Therefore the current study was designed to compare paediatric patients pain perception during dental injection using new needle-free injection system NF or traditional injection method TM In addition secondary outcomes such as dosage of local anesthetics used ml and duration of the analgesia effect min were assessed The expectation and tested hypotheses were that the needle-free method would produce lower pain injection and lower dosage of local anesthetics during the dental procedure
Thus numerious methods and techniques have been suggested to minimizereduce pain due to infiltration of LA agents including application of topical anesthesia pre-cooling injection site pressure administration to injection site applying laser as pretreatment method warming and buffering the local anesthetics tactile stimulations distraction technique use of narrow needles and slow delivery of the injection solution computerized injection systems employing modern devices such VibraJect DentalVibe or Aculief have been tried out to allay the fears of child patients However none of them gained universal acceptance and more situations and techniques need to be evaluated to improve stress management among patients in dental settings
During the administration of a LA injection an anxious patient might perceive more severe pain of longer duration than would a less anxious patient Visually and psychologyically the dental syringe is perceived as a threatening instrument especially by children Fear of pain from the needle has been frequently indicated to be the most fear-evoking stimulus for dentally anxious children
The needle- free injection system may yield a higher level of comfort because it involves no puncture or injection phase and has emerged as a novel alternative to traditional needle- based techniques The Comfort-inTM system Mika Medical Busan Korea is a recent dental device that uses a needle-free injection technique to administer local anesthesia This system is a patented device using the liquid jet system to inject the anesthetic solution rapidly from a 015-mm hole with high pressure The use of this needle-free local anaesthesia system in dentistry can be of a help in treating needle phobia patients To the extent of investigators knowledge there were few studies have evaluated the effectiveness of this new injection technique on primary molars in children Investigators feel that paediatric patients are the target group for whom pain control should be adequately followed Therefore the current study was designed to compare paediatric patients pain perception during dental injection using new needle-free injection system NF or traditional injection method TM In addition secondary outcomes such as dosage of local anesthetics used ml and duration of the analgesia effect min were assessed The expectation and tested hypotheses were that the needle-free method would produce lower pain injection and lower dosage of local anesthetics during the dental procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None