Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606587
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children
Status:
COMPLETED
Status Verified Date:
2024-09
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 goal of this randomized clinical trial is to compare two different injection methods in children The main question it aims to answer is
Is the needle-free injection method more painless than the traditional dental method
Two different methods will be used for children to perform anesthesia for extraction permanent molars
Is the needle-free injection method more painless than the traditional dental method
Two different methods will be used for children to perform anesthesia for extraction permanent molars
Detailed Description:
Study Groups and Study Design 56 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study For randomization methods were written on two different envelopes and the child was allowed to choose the envelope The child was assigned to the selected method Group Control Application of Traditional Dental Injection Method Palatal injection It was applied 5-10 mm below the palatal gingival margin on the attached gum and with a 45-degree needle angle After needle entry 02-03 mL of anesthetic solution was stored when bone contact was removed 3-5 mm 1 mL Articaine Hydrochloride Ultracaine D-S forte Hoechst Canada containing 1100000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections 25 patients were included in this group and the procedure was performed After waiting for 5 minutes the anesthetized area was probed with the help of a probe probing gingiva to check whether the anesthesia had taken effect Afterwards buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed Group Experimental Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar Using a silicone flat cap it was placed 5 mm below the palatal gingival margin close to the free gingiva and with a steep angle 03 ml of anesthetic solution was administered by pressing the jet injection system button 1 mL Articaine Hydrochloride Ultracaine D-S forte Hoechst Canada containing 1100000 epinephrine was used as a local anesthetic agent in the injections 31 patients were included in this group and the procedure was performed After waiting for 2 minutes the anesthetized area was probed with the help of a probe probing gingiva to check whether the anesthesia had taken effect Afterwards buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed
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