Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793905
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-02-07
Brief Title:
Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Evaluation of the Effect of Buffered Anesthetic Solution Lidocaine 2 in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars
Status:
COMPLETED
Status Verified Date:
2023-09
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:
In a prospective randomized clinical trial triple-blind split-mouth study 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis The test agent was 2 lidocaine with 180000 epinephrine buffered with sodium bicarbonate 84 at a ratio of 110 as opposed to the control agent which was non- buffered 2 lidocaine with 180000 epinephrine The pain will be assessed during inferior alveolar nerve block injection IANB and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale the objective sound eye and motor SEM scale and the physiological pain scale pulse rate using a pulse oximeter The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain Endo-ice has been used to assess the onset of pulp anesthesia
Detailed Description:
In a prospective randomized clinical trial and triple-blind split mouth study 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis Random numbers between 1 to 40 were assigned to patients with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine The solutions have been switched up for the second session which has been set for one week later The test agent was 2 lidocaine with 180000 epinephrine buffered with sodium bicarbonate 84 at a ratio of 110 as opposed to the control agent non-buffering 2 lidocaine with 180000 epinephrine Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate 84 with the anaesthetic solution lidocaine 2 with epinephrine 180000 in a 110 ratio by volume Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection IANB The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale the objective sound eye and motor SEM scale and the physiological pain scale pulse rate using a pulse oximeter After administering the IANB injection the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective objective and physiological pain scales Finally the numerical data will be statistically analysed and any statistically significant values will be investigated
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