Articaine Efficacy and Safety for Children Below Age of 4-years

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04061265
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 39.2

Study Details

Study Description

Brief Summary

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Condition or Disease	Intervention/Treatment	Phase
Behaviour Assessment; Pain	Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml; Drug: lidocaine hydrochloride 2% and epinephrine 1:100000	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial
• Actual Study Start Date: Aug 25, 2019
• Actual Primary Completion Date: Jan 15, 2020
• Actual Study Completion Date: Jan 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine 2% group lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd)	Drug: lidocaine hydrochloride 2% and epinephrine 1:100000; Local anesthetic agent
Experimental: Articaine 4% articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd)	Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml; Local anesthetic agent

Outcome Measures

Primary Outcome Measures

1. Pain assessment [During the procedures]

   FLACC scale

2. Behavior [before and after the procedures]

   Frankl behaviour scale

Secondary Outcome Measures

1. postoperative complications [24 hours after the procedures]

   Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 37 Months to 47 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

• The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ngwa Khattab	Minya	Minia	Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

• Principal Investigator: Ahmad Elheeny, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Elheeny, Lecturer of Pediatri, Faculty of Dentistry, Minia University, Minia University
• ClinicalTrials.gov Identifier: NCT04061265
• Other Study ID Numbers: 245
• First Posted: Aug 19, 2019
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmad Elheeny, Lecturer of Pediatri, Faculty of Dentistry, Minia University, Minia University: Articaine, local anaesthesia, child, pain
• Additional relevant MeSH terms: Lidocaine; Epinephrine; Carticaine

Study Results

No Results Posted as of Feb 17, 2020