a Spilt Mouth Clinical Comparative Evaluation of the Electronic Anesthetic Efficacy
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mouetaz Kheirallah
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Onset time
Overview
Brief Summary
A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect
Detailed Description
Study Design:
The mouth will be split in half using a split mouth study. The lower anterior teeth will be injected with a conventional local anesthetic syringe on one side, and the patient will be injected with an electronic anesthetic syringe on the other side.
The study will be conducted on a sample of volunteers aged 18 to 30 years at the Faculty of Dentistry at Al-Andalus University.
The objectives and procedure will be explained to each group of patients, and informed consent will be obtained from each patient to accept the research procedures.
A 2% non-vasoconstrictor lidocaine local anesthetic will be used for all patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Masking Description
single blinded
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •". Age ranged from 20 to 30 years , no menstrual cycle, The participants were not allergic to local anesthetics, had not used medication that would alter pain perception, none of them had not ever experienced Smartject injection before, and none of them were alcoholics or smokers, The participants were not allergic to local anesthetics.
Exclusion Criteria
- •allergic to local anesthetics ,females during menstural cycle ,bad oral care.
Outcomes
Primary Outcomes
Onset time
Time Frame: 2 month
was considered as the period between the end of the injection and the first subsequent Onset time was considered as the period between the end of the injection and the first subsequent readings without response. After this period, the tooth was tested every 10 minutes until readings returned to the baseline threshold. Each subject was asked to record the time of return to normal sensation in the lower lip
Secondary Outcomes
- Visual Analogue Scale (VAS)(2 month)
Investigators
Mouetaz Kheirallah
Ph.D., OMFS, DDS, Associate Professor
Arab University for Science and Technology