Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448507
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-05-17
Brief Title:
Comparison of a Needle-free Local Anesthetic Technique With Traditional Syringe Needle Syringe Technique for the Restoration of Primary Molars and Permanent Molars
Sponsor:
University of Jazan
Organization:
University of Jazan
Study Overview
Official Title:
Effectiveness of a Needle-free Local Anesthetic Technique Compared to the Traditional Syringe Technique for the Restoration of Primary Molars and Young Permanent Molars A Single-blind 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system Traditional syringe system for restoration of Primary and young permanent teeth The main questions it aims to answer are
1 To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population
2 To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe Traditional syringe system method in a pediatric population
3 Time required to deliver anesthesia using needle free system vs Needle syringe traditional syringe system
Participants who enrolled in the study will be anesthetized according to the respective groups ie needle free system and traditional dental needle system and restoration will be done
1 To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population
2 To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe Traditional syringe system method in a pediatric population
3 Time required to deliver anesthesia using needle free system vs Needle syringe traditional syringe system
Participants who enrolled in the study will be anesthetized according to the respective groups ie needle free system and traditional dental needle system and restoration will be done
Detailed Description:
Before the start of the study a written informed consent and ascent was obtained from each parent of the children included in the study stating they accepted the treatment Ethical clearance will be obtained before the start of the study Patients reporting to the dental clinics college of dentistry will be included in the study
Sample size estimation
the sample size was estimated to be twenty-one 21 Twenty percent of the estimated sample size was added to compensate for sampling loss if any thus the final sample size accounted to a total of twenty-five 25 participants in each group
study design It was a single blinded randomized controlled trial
Randomization
Children will be allocated into one of the following two groups using a simple randomization method with a random number table employing the sequentially numbered opaque sealed envelopes method of allocation concealment
Group I All participants in this group were subjected to the traditional needle syringe system Local infiltration of Scandicaine 2 Speciale Mepivacaine Hydrochloride and adrenaline was administered using a traditional needle syringe equipped with a 27-gauge needle
Group II Participants in this group received the needle-free injection system specifically the INJEX Injex Pharma AG Germany 03ml of 2 Scandicaine will be adminsitered
Intervention procedure
To avoid any operator-related bias a single operator will manage the entire anesthesia protocol for all participants in the trial Employing the tell-show-do technique all relevant treatment equipment and protocols were introduced and explained to the participants The injection process was fully described using appropriate euphemisms Before administering the injection the treatment area at the injection site was cleansed using a sterile dry gauze and a small amount of topical anesthetic Benzocaine 20 NJ USA was applied remaining in place for at least one minute Following the application of topical anesthesia local anesthesia was administered based on the participants assigned group After a standard waiting period of three minutes for the onset of anesthesia dental caries was removed dycal applied and final restoration with composite was done
Sample size estimation
the sample size was estimated to be twenty-one 21 Twenty percent of the estimated sample size was added to compensate for sampling loss if any thus the final sample size accounted to a total of twenty-five 25 participants in each group
study design It was a single blinded randomized controlled trial
Randomization
Children will be allocated into one of the following two groups using a simple randomization method with a random number table employing the sequentially numbered opaque sealed envelopes method of allocation concealment
Group I All participants in this group were subjected to the traditional needle syringe system Local infiltration of Scandicaine 2 Speciale Mepivacaine Hydrochloride and adrenaline was administered using a traditional needle syringe equipped with a 27-gauge needle
Group II Participants in this group received the needle-free injection system specifically the INJEX Injex Pharma AG Germany 03ml of 2 Scandicaine will be adminsitered
Intervention procedure
To avoid any operator-related bias a single operator will manage the entire anesthesia protocol for all participants in the trial Employing the tell-show-do technique all relevant treatment equipment and protocols were introduced and explained to the participants The injection process was fully described using appropriate euphemisms Before administering the injection the treatment area at the injection site was cleansed using a sterile dry gauze and a small amount of topical anesthetic Benzocaine 20 NJ USA was applied remaining in place for at least one minute Following the application of topical anesthesia local anesthesia was administered based on the participants assigned group After a standard waiting period of three minutes for the onset of anesthesia dental caries was removed dycal applied and final restoration with composite was done
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