NCT02788890 - Vital Signs Changes During Dental Procedures | Crick | Crick

Vital Signs Changes During Dental Procedures

N/ACompletedNCT02788890

Riyadh Colleges of Dentistry and Pharmacy50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

50

Conditions

Vital Signs Changes During Dental Procedures

Interventions

Scaling without LAPROCEDURE

The patient will undergo a supragingival scaling procedure without local anesthesia

Simple restoration under LAPROCEDURE

The patient will undergo a simple dental restoration procedure under local anesthesia

Simple exodontia under LAPROCEDURE

The patient will undergo a simple dental extraction procedure under local anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Riyadh Colleges of Dentistry & Pharmacy

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT

Body temperature measured in Celsius using infrared non-contact digital thermometer

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative