Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 130
- Primary Endpoint
- Intraoperative pain.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
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 Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Artinibsa
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.
Intervention: Artinibsa (Other)
Artpharma
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
Intervention: Artpharma (Other)
Outcomes
Primary Outcomes
Intraoperative pain.
Time Frame: immediate
Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).
Secondary Outcomes
- Onset of anesthesia.(Immediate)
- Pain during injection(success rate).(immediate)
- The sensation after injection.(Immediate)
Investigators
Hafedha Hashem Abdullah
Principle Investigator
Cairo University