Vital Signs Changes During Dental Procedures

NCT02788890 | Completed

• 1 other identifier: FRP/2016/43
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Signs Changes During Dental Procedures

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (6)

• 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 Operative Procedure from the baseline MAP

  Baseline, during anesthesia injection, intraoperative, 5-min postoperative

Study Arms (3)

Control Group (T0)

ACTIVE COMPARATOR

The supragingival scaling without LA

Procedure: Scaling without LA

Test Group 1 (T1)

EXPERIMENTAL

The simple restoration under LA

Procedure: Simple restoration under LA

Test Group 2 (T2)

EXPERIMENTAL

The simple exodontia under LA

Procedure: Simple exodontia under LA

Interventions

Scaling without LA PROCEDURE

The patient will undergo a supragingival scaling procedure without local anesthesia

Control Group (T0)

Simple restoration under LA PROCEDURE

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

Test Group 1 (T1)

Simple exodontia under LA PROCEDURE

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

Test Group 2 (T2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry & Pharmacy

Riyadh, 11681, Saudi Arabia

Location

MeSH Terms

Interventions

Tooth Exfoliation

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ra'ed G Salma

  Riyadh Colleges of Dentistry and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The care provider was not aware of study objectives. The outcomes assessor was not involved in the data collection.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 2, 2016
• Study Start: February 10, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

SA (1)