Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Dental anxiety (subjective) |
Units on a Scale (Patient's dental anxiety level was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for dental anxiety.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as no anxiety. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.) |
through study completion, an average of 12 months |
|
Primary |
Dental anxiety (objective) |
Units on Saliva cortisol levels (Dental anxiety was evaluated with Enzyme-linked immunosorbent assay after treatment.The patients were measured from 0 to 200 nmol/L for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-28 nmol/L'' are considered as better outcome. Patients who were have these scores described no dental anxiety for deep sedation. The worst outcome is considered as the anxious patients have ">28 nmol/L ". Each value range for each time interval evaluated as count of patient and presented as percentage.) |
through study completion, an average of 12 months |
|
Primary |
Depth of sedation |
Units on a Scale (Depth of sedation was evaluated with Ramsay Sedation Scale during the sedation. Observer signed from 0 to 5 score for depth of sedation during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "4-5" scores are considered as better outcome. Patients who were signed these scores described as sedated patients for dental treatment. The worst outcome is considered as the patients signed "0-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.) |
through study completion, an average of 12 months |
|
Primary |
Postperative complications |
Units on a Scale ( Postoperative complications were evaluated with a form which was included absence or presence of agitation, hypersalivation, nausea-vomiting and double vision. Observer signed absence or presence for each complications after the treatment.The data were collected and statistically analysed using by the numerical data) |
through study completion, an average of 12 months |
|
Primary |
Perioperative complications |
Units on a Scale (Perioperative complications were evaluated with a form which was included absence or presence of local injection pain, cough, saturation drop and spontaneous movement. Observer signed absence or presence for each perioperative complications during the deep sedation.The data were collected and statistically analysed using by the numerical data) |
through study completion, an average of 12 months |
|
Secondary |
Heart Rate |
Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation) |
through study completion, an average of 12 months |
|
Secondary |
Systolic and diastolic arterial pressure |
Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation) |
through study completion, an average of 12 months |
|
Secondary |
Oxygen saturation |
Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation) |
through study completion, an average of 12 months |
|