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Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Besides, the level of anxiety was established as one of the most crucial predictors of dental anesthesia level.
Techniques and equipment such as topical anesthetic, cold spray, applying pressure, vibratory devices, distraction techniques, sedation medications, have been developed and utilized to reduce pain or fear of dental injections or increase the efficacy of anesthesia. However it is the sight and sensation of a needle that was found by almost 25% of patients to be extremely anxiety provoking stimuli in a survey to determine what dental patients truly fear.
Therefore, Needleless devices that were developed to provide anesthesia without injections would reduce patients' apprehension and anxiety levels resulting in a profound anesthesia for a proper duration of time
The aim of the study, treatment procedures, possible side effects and treatment alternatives will be explained to the patients. Patients will be asked to follow the general instructions and sign a printed informed consent. Patients will be asked to fill the outcomes data charts honestly and accurately.
Eligible patients will be randomly divided into two equal groups according to randomization mechanism: Group 1 (Comfort-In Jet Anesthesia) and Group 2 (Local Infiltration Anesthesia)
Pre-operative measures (for all groups):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle-less jet anaesthesia | Experimental | Infiltration anaesthesia without needle |
|
| Conventional injection anaesthesia | Active Comparator | Regular infiltration anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle-less jet anaesthesia | Device | Infiltration anesthesia without needle depending on injection pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra operative pain | Using NRS score | Up to One hour |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of pulpal anaesthesia | Electric pulp tester will be used to measure the time taken for gaining profound anesthesia | Up to Ten minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nader W Ramsis | Contact | 01225321044 | nader.wadie@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Shaimaa I Bakry | Cairo University | Study Director |
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| Conventional Injection Anesthesia | Device | Regular Infiltration local anesthesia |
|