Vital Signs Changes During Dental Procedures

Study Overview
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Brief Summary
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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.

Official Title
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Vital Signs Changes During Different Dental Procedures in Otherwise Healthy Adult Patients.

Conditions
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Vital Signs Changes During Dental Procedures

Intervention / Treatment
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* Procedure: Scaling without LA
* Procedure: Simple restoration under LA
* Procedure: Simple exodontia under LA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients included are the ones planned for the following 3 dental treatments in 3 separate visits to done by the same dentist: supragingival scaling without local anesthesia (LA), simple dental extraction under LA, and simple restoration under LA. Exclusion Criteria: Patients under 18 years old Patients with a known medical history of any systemic disease like hypertension, diabetes, and bleeding disorders Patients with history of cardiac surgery; including pace maker insertion Patients on medications Smokers, alcoholics, and drug abusers Pregnant patients Patients with an acute infection with or without fever Patients with a preoperative pain score of 4 or more on a visual analogue scale out of 10; where 0 = no pain and 10 = worst pain imaginable Patients with 2 or more simultaneous dental procedures per visit Patients with undiagnosed hypertension who are found to be hypertensive according to the World Health Organization (WHO) definition on the base-line preoperative readings

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (T0)<br>The supragingival scaling without LA | Procedure: Scaling without LA<br>* The patient will undergo a supragingival scaling procedure without local anesthesia<br>|
| Experimental: Test Group 1 (T1)<br>The simple restoration under LA | Procedure: Simple restoration under LA<br>* The patient will undergo a simple dental restoration procedure under local anesthesia<br>|
| Experimental: Test Group 2 (T2)<br>The simple exodontia under LA | Procedure: Simple exodontia under LA<br>* The patient will undergo a simple dental extraction procedure under local anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |