Vital Signs Changes During Dental Procedures

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

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 Overview

• Status: Completed
• Conditions: Vital Signs Changes During Dental Procedures
• Intervention / Treatment: Procedure: Scaling without LA; Procedure: Simple restoration under LA; Procedure: Simple exodontia under LA

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11681
    • Riyadh Colleges of Dentistry & Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Ra'ed G Salma, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FRP/2016/43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No