Vital Signs Changes During Different Dental Procedures in Otherwise Healthy Adult Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The care provider was not aware of study objectives. The outcomes assessor was not involved in the data collection.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT
Time Frame: Baseline, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change in Respiratory Rate (RR) during Dental Extraction from the baseline RR
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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)
Change in Heart Rate (HR) during Operative Procedure from the baseline HR
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Periodontal Therapy from the baseline SpO2
Time Frame: Baseline, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Dental Extraction from the baseline DBP
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Body Temperature (BT) during Operative Procedure from the baseline BT
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change from baseline Body Temperature (BT) during Dental Extraction from the baseline BT
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change in Respiratory Rate (RR) during Periodontal Therapy from the baseline RR
Time Frame: Baseline, intraoperative, 5-min postoperative
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)
Change in Respiratory Rate (RR) during Operative Procedure from the baseline RR
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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)
Change in Heart Rate (HR) during Periodontal Therapy from the baseline HR
Time Frame: Baseline, intraoperative, 5-min postoperative
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
Change in Heart Rate (HR) during Dental Extraction from the baseline HR
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Operative Procedure from the baseline SpO2
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Dental Extraction from the baseline SpO2
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Periodontal Therapy from the baseline SBP
Time Frame: Baseline, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Operative Procedure from the baseline SBP
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Dental Extraction from the baseline SBP
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Periodontal Therapy from the baseline DBP
Time Frame: Baseline, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Operative Procedure from the baseline DBP
Time Frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Secondary Outcomes
- Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP(Baseline, during anesthesia injection, intraoperative, 5-min postoperative)
- Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP(Baseline, intraoperative, 5-min postoperative)
- Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP(Baseline, during anesthesia injection, intraoperative, 5-min postoperative)
- Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP(Baseline, during anesthesia injection, intraoperative, 5-min postoperative)
- Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP(Baseline, intraoperative, 5-min postoperative)
- Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP(Baseline, during anesthesia injection, intraoperative, 5-min postoperative)
Investigators
Ra'ed Salma
Assistant Professor Oral and Maxillofacial Surgery
Riyadh Colleges of Dentistry and Pharmacy