Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the vital signs changes during 3 different dental procedures performed for the same patient by the same dentist. The patients will be selected randomly and should all be healthy adults.
The aim is to look for any significant changes in the major vital signs (heart rate, respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body temperature) during specified dental procedures (scaling, simple restoration, and simple exodontia) and compare the changes between the 3 procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (T0) | Active Comparator | The supragingival scaling without LA |
|
| Test Group 1 (T1) | Experimental | The simple restoration under LA |
|
| Test Group 2 (T2) | Experimental | The simple exodontia under LA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling without LA | Procedure | The patient will undergo a supragingival scaling procedure without local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT | Body temperature measured in Celsius using infrared non-contact digital thermometer | Baseline, intraoperative, 5-min postoperative |
| Change in Body Temperature (BT) during Operative Procedure from the baseline BT | Body temperature measured in Celsius using infrared non-contact digital thermometer | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change from baseline Body Temperature (BT) during Dental Extraction from the baseline BT | Body temperature measured in Celsius using infrared non-contact digital thermometer | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Respiratory Rate (RR) during Periodontal Therapy from the baseline RR | Respiratory rate is measured by observing the chest and/or abdominal movements and count the number of respirations out loud for one full minute. One respiration consists of one complete rise and fall of the chest (inhalation and exhalation of air) | Baseline, intraoperative, 5-min postoperative |
| Change in Respiratory Rate (RR) during Operative Procedure from the baseline RR | Respiratory rate is measured by observing the chest and/or abdominal movements and count the number of respirations out loud for one full minute. One respiration consists of one complete rise and fall of the chest (inhalation and exhalation of air) | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Respiratory Rate (RR) during Dental Extraction from the baseline RR |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg | Baseline, intraoperative, 5-min postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ra'ed G Salma | Riyadh Colleges of Dentistry and Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riyadh Colleges of Dentistry & Pharmacy | Riyadh | 11681 | Saudi Arabia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
The care provider was not aware of study objectives. The outcomes assessor was not involved in the data collection.
| Simple restoration under LA | Procedure | The patient will undergo a simple dental restoration procedure under local anesthesia |
|
| Simple exodontia under LA | Procedure | The patient will undergo a simple dental extraction procedure under local anesthesia |
|
Respiratory rate is measured by observing the chest and/or abdominal movements and count the number of respirations out loud for one full minute. One respiration consists of one complete rise and fall of the chest (inhalation and exhalation of air) |
| Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Heart Rate (HR) during Periodontal Therapy from the baseline HR | The heart rate will be recorded using a non-invasive infrared pulse oximeter placed on the patient's left index finger attached to an ambulatory digital monitor | Baseline, intraoperative, 5-min postoperative |
| Change in Heart Rate (HR) during Operative Procedure from the baseline HR | The heart rate will be recorded using a non-invasive infrared pulse oximeter placed on the patient's left index finger attached to an ambulatory digital monitor | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Heart Rate (HR) during Dental Extraction from the baseline HR | The heart rate will be recorded using a non-invasive infrared pulse oximeter placed on the patient's left index finger attached to an ambulatory digital monitor | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Peripheral Oxygen Saturation (SpO2) during Periodontal Therapy from the baseline SpO2 | The SpO2 will be recorded using a non-invasive infrared pulse oximeter placed on the patient's index finger attached to an ambulatory digital monitor | Baseline, intraoperative, 5-min postoperative |
| Change in Peripheral Oxygen Saturation (SpO2) during Operative Procedure from the baseline SpO2 | The SpO2 will be recorded using a non-invasive infrared pulse oximeter placed on the patient's index finger attached to an ambulatory digital monitor | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Peripheral Oxygen Saturation (SpO2) during Dental Extraction from the baseline SpO2 | The SpO2 will be recorded using a non-invasive infrared pulse oximeter placed on the patient's index finger attached to an ambulatory digital monitor | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Systolic Blood Pressure (SBP) during Periodontal Therapy from the baseline SBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg | Baseline, intraoperative, 5-min postoperative |
| Change in Systolic Blood Pressure (SBP) during Operative Procedure from the baseline SBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Systolic Blood Pressure (SBP) during Dental Extraction from the baseline SBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Diastolic Blood Pressure (DBP) during Periodontal Therapy from the baseline DBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg | Baseline, intraoperative, 5-min postoperative |
| Change in Diastolic Blood Pressure (DBP) during Operative Procedure from the baseline DBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Diastolic Blood Pressure (DBP) during Dental Extraction from the baseline DBP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation: MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg | Baseline, intraoperative, 5-min postoperative |
| Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation: MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |
| Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP | The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation: MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg | Baseline, during anesthesia injection, intraoperative, 5-min postoperative |