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To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.
After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starpen automatic injection device | Experimental | effect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars |
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| Conventional syringe | Active Comparator | Conventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starpen automatic injection device | Device | Starpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective pain during injection | Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Objective pain during infiltration | Objective pain perception during infiltration anesthesia using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| conventional syringe | Procedure | injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle |
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| during procedure |
| Subjective pain during extraction | Subjective pain perception during extraction of maxillary primary molars using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain. | during procedure |
| Objective pain during extraction | Objective pain perception during extraction of maxillary primary molars using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain. | during procedure |
| Physiological parameters ( heart rate ) | Physiological parameters ( heart rate) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 70-100 bpm is the normal range at rest and higher heart rate readings reflects anxiety/pain/ discomfort . | Readings will be taken before and during anesthesia injection and during extraction. |
| Physiological parameter ( oxygen saturation) | Physiological parameter ( oxygen saturation) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 95-100% is the normal range on room air . A drop below 94% indicates hypoxemia and immediate assessment must be for airway and breathing. | Readings will be taken before and during anesthesia injection and during extraction. |