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Completed

NCT Number: NCT02788890

Vital Signs Changes During Dental Procedures

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.

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Key information

Conditions

Vital Signs Changes During Dental Procedures

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riyadh Colleges of Dentistry & Pharmacy

Riyadh, 11681, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling without LA

Procedure

The patient will undergo a supragingival scaling procedure without local anesthesia

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Secondary outcomes

  1. Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP

    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. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg

  2. Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP

    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. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg

  3. Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP

    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. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg

  4. Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP

    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. The MAP is then calculated using the following equation:

    MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg

  5. Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP

    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. The MAP is then calculated using the following equation:

    MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg

  6. Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP

    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. The MAP is then calculated using the following equation:

    MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.