Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576609
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Effectiveness of INJEX Versus Traditional Syringe During Restoration of Primary Teeth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of INJEX Versus Traditional Syringe During Restoration of Primary Teeth A Randomized Split-mouth 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 main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system INJEX and the conventional syringe technique The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system INJEX and the conventional syringe technique
The main questions it aims to answer are
1 To evaluate pain perception for restoration of primary molars with a needle free system in a pediatric population
2 To evaluate pain perception for restoration of Primary molars 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 INJEX needle free system and traditional dental needle system and restoration will be done
The main questions it aims to answer are
1 To evaluate pain perception for restoration of primary molars with a needle free system in a pediatric population
2 To evaluate pain perception for restoration of Primary molars 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 INJEX 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 determined using the following formula based on a difference in mean Face Legs Activity Cry and Consolability FLACC scores of 12 and a pooled standard deviation of 189 Sample Size n 2Sp2 Z 1-α2Z1-β 2 µd2 where Z 1-α2 196 for a 95 confidence interval Z1-β 084 for 80 power Sp2 pooled standard deviation µd 12 difference in mean between groups Substituting these values the sample size was estimated to be 21 An additional 20 of the estimated sample size was added to account for any potential sampling loss bringing the final sample size to a total of 25 teeth in each group
study design It was a split mouth randomized controlled trial
Randomization
Teeth designated for restoration were assigned to one of two groups using a simple randomization method with a 11 allocation ratio The allocation was performed using a predetermined list with the first list for the right side and the second for the left side Allocation concealment was maintained through sealed envelopes until the time of intervention to prevent selection bias On the intervention day patients identified their number on either the right or left side lists
Group I All teeth in this group underwent restoration using the traditional syringe system Making use of a conventional syringe fitted with a 27-gauge needle Hogen Spitze C-K Dental INDCO LTD local infiltration of Scandicaine 2 Special mepivacaine hydrochloride and adrenaline was given
Group II Teeth in this group received treatment with the needle-free injection system INJEX INJEX Pharma AG Germany
Intervention procedure To mitigate any operator-related bias a single operator conducted the entire anesthesia protocol for all participants in the trial Utilizing the Tell-Show-Do technique all relevant treatment equipment and protocols were introduced and explained The injection was thoroughly described using appropriate euphemisms or age-appropriate language
A sterile dry gauze was used to cleanse the treatment area at the injection site before administering LA Following this a very small quantity of topical anesthetic Benzocaine 20 NJ USA was given and left to remain for a minimum time of 1 minute Following the application of topical anesthesia LA was administered based on the participants assigned group
After a standard waiting time of 3 minutes for the anesthesia to take effect dental caries were removed The pulp capping material Dycal Dentsply Caulk Milford DE USA was placed and a type IX glass ionomer cement GC Corporation Tokyo Japan liner was applied before the final restoration with composite material
Sample size estimation
The sample size was determined using the following formula based on a difference in mean Face Legs Activity Cry and Consolability FLACC scores of 12 and a pooled standard deviation of 189 Sample Size n 2Sp2 Z 1-α2Z1-β 2 µd2 where Z 1-α2 196 for a 95 confidence interval Z1-β 084 for 80 power Sp2 pooled standard deviation µd 12 difference in mean between groups Substituting these values the sample size was estimated to be 21 An additional 20 of the estimated sample size was added to account for any potential sampling loss bringing the final sample size to a total of 25 teeth in each group
study design It was a split mouth randomized controlled trial
Randomization
Teeth designated for restoration were assigned to one of two groups using a simple randomization method with a 11 allocation ratio The allocation was performed using a predetermined list with the first list for the right side and the second for the left side Allocation concealment was maintained through sealed envelopes until the time of intervention to prevent selection bias On the intervention day patients identified their number on either the right or left side lists
Group I All teeth in this group underwent restoration using the traditional syringe system Making use of a conventional syringe fitted with a 27-gauge needle Hogen Spitze C-K Dental INDCO LTD local infiltration of Scandicaine 2 Special mepivacaine hydrochloride and adrenaline was given
Group II Teeth in this group received treatment with the needle-free injection system INJEX INJEX Pharma AG Germany
Intervention procedure To mitigate any operator-related bias a single operator conducted the entire anesthesia protocol for all participants in the trial Utilizing the Tell-Show-Do technique all relevant treatment equipment and protocols were introduced and explained The injection was thoroughly described using appropriate euphemisms or age-appropriate language
A sterile dry gauze was used to cleanse the treatment area at the injection site before administering LA Following this a very small quantity of topical anesthetic Benzocaine 20 NJ USA was given and left to remain for a minimum time of 1 minute Following the application of topical anesthesia LA was administered based on the participants assigned group
After a standard waiting time of 3 minutes for the anesthesia to take effect dental caries were removed The pulp capping material Dycal Dentsply Caulk Milford DE USA was placed and a type IX glass ionomer cement GC Corporation Tokyo Japan liner was applied before the final restoration with composite material
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