Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201949
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2024-01-01
Brief Title:
Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars
Sponsor:
Hams Hamed Abdelrahman
Organization:
Alexandria University
Study Overview
Official Title:
Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Background Articaine hydrochloride has steadily grown in popularity and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block IANB which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues Therefore the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable
Aim Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure
Materials and Methods The study will be two-arm randomized controlled clinical trial parallel design and it will be setup and reported according the CONSORT guidelines A total of 52 healthy children aged 5-6 years will be selected from Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Alexandria University Egypt Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy Written informed consent will be obtained from guardian Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used
Group I Experimental group n 26 assigned to articaine infiltration anesthesia while group II Control group n 26 assigned to the conventional IANB injection articaine
Pain will be assessed by three diferent methods physiological method using the Heart rate as vital parameter of pain and will be recorded at base line during injection pulpotomy and stainless steel crown SSC preparation Objective method using Sensory Eye Motor SEM scale and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale
Aim Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure
Materials and Methods The study will be two-arm randomized controlled clinical trial parallel design and it will be setup and reported according the CONSORT guidelines A total of 52 healthy children aged 5-6 years will be selected from Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Alexandria University Egypt Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy Written informed consent will be obtained from guardian Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used
Group I Experimental group n 26 assigned to articaine infiltration anesthesia while group II Control group n 26 assigned to the conventional IANB injection articaine
Pain will be assessed by three diferent methods physiological method using the Heart rate as vital parameter of pain and will be recorded at base line during injection pulpotomy and stainless steel crown SSC preparation Objective method using Sensory Eye Motor SEM scale and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale
Detailed Description:
None
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