Pain
Conditions
Keywords
Articaine, Infiltration technique, Restoration primary teeth, Intraoperative pain
Brief summary
The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.
Detailed description
Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.
Interventions
OTHERArtinibsa
local anaesthetic solution 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 4%Articaine 1:100000.
OTHERArtpharma
Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
8 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 8-10 years old * Mentally capable of communication * Cooperative children need restorative treatment
Exclusion criteria
* Medically compromised patient * Primary teeth requiring pulpotomy or pulpectomy * Parent or guardians who refuse participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Pain: Wong Baker rating scale | During the procedure. | Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of anesthesia | Immediately after the injection. | is measuring by using stop watch and the unite is minutes. the unit is : minutes |
| The sensation after injection | Immediately after the injection. | Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No) |
| Time of numbness disappear | 2 hours postoperatively after the procedure. | Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No). |
Contacts
Primary ContactAmani ALAidaros, Master
Backup ContactFatma Korany Ismail, Phd
Outcome results
None listed