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Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04221685
Enrollment
130
Registered
2020-01-09
Start date
2020-12-01
Completion date
2021-12-01
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

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

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.

Detailed description

Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons

Interventions

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Pain during injection(success rate).immediatePain during injection:is evaluated the success rate of anesthesia by using the visual analogue scale and measuring unite is categorical.
Onset of anesthesia.Immediateonset of anesthesia:is measuring by using stop watch and the unit is minutes
The sensation after injection.ImmediateThe sensation after injection: is evaluated the effect of the anesthesia by checking mucous using the probe and measuring unite is binary (Yes or No).

Contacts

Primary ContactHafedha Zain, Master
hafedha.abdullah@dentistry.cu.edu.eg01114341678
Backup ContactFatma Korany Ismail, Phd
fatmadent@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026