Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

NCT04221685 | Unknown

• 1 other identifier: IOP Use Artp Vs Artin inf
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.

Conditions

Pain, Postoperative

Keywords

Articaine; Extraction primary teeth; Infiltration technique; Postoperative pain; Intraoperative pain

Outcome Measures

Primary Outcomes (1)

• Intraoperative pain.

  Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).

  immediate

Secondary Outcomes (3)

• Pain during injection(success rate).

  immediate

• Onset of anesthesia.

  Immediate

• The sensation after injection.

  Immediate

Study Arms (2)

Artinibsa

ACTIVE COMPARATOR

Powerful local anaesthetic with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.4%Articaine 1:100000.

Other: Artinibsa

Artpharma

EXPERIMENTAL

ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride,Epinephrine (D.C.I) (tartrate) 0.01 mg

Other: Artpharma

Interventions

Artpharma OTHER

ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg

Artpharma

Artinibsa OTHER

Powerful local anaesthetic with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains: Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg

Artinibsa

Eligibility Criteria

• Age: 6 Years - 9 Years
• Gender Eligibility Details: 6-9years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-9 years.
• Children with maxillary primary molars indicated for extraction.

You may not qualify if:

• Children with medical conditions.
• Uncooperative children.
• Parents or guardians who refuse participating in the study.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Hafedha Zain, Master

CONTACT

01114341678; hafedha.abdullah@dentistry.cu.edu.eg

Fatma Korany Ismail, Phd

CONTACT

fatmadent@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) single ( participant ) because the two interventions used in this trial are easily recognized by the investigator but the participant and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share