Clinical trial NCT02788890: Vital Signs Changes During Dental Procedures
Official title: Vital Signs Changes During Different Dental Procedures in Otherwise Healthy Adult Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Signs Changes During Dental Procedures
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Body Temperature (BT) during Operative Procedure from the baseline BT
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change from baseline Body Temperature (BT) during Dental Extraction from the baseline BT
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Respiratory Rate (RR) during Periodontal Therapy from the baseline RR
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Respiratory Rate (RR) during Operative Procedure from the baseline RR
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Respiratory Rate (RR) during Dental Extraction from the baseline RR
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Heart Rate (HR) during Periodontal Therapy from the baseline HR
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Heart Rate (HR) during Operative Procedure from the baseline HR
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Heart Rate (HR) during Dental Extraction from the baseline HR
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Peripheral Oxygen Saturation (SpO2) during Periodontal Therapy from the baseline SpO2
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Peripheral Oxygen Saturation (SpO2) during Operative Procedure from the baseline SpO2
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Peripheral Oxygen Saturation (SpO2) during Dental Extraction from the baseline SpO2
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Systolic Blood Pressure (SBP) during Periodontal Therapy from the baseline SBP
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Systolic Blood Pressure (SBP) during Operative Procedure from the baseline SBP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Systolic Blood Pressure (SBP) during Dental Extraction from the baseline SBP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Diastolic Blood Pressure (DBP) during Periodontal Therapy from the baseline DBP
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Diastolic Blood Pressure (DBP) during Operative Procedure from the baseline DBP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Diastolic Blood Pressure (DBP) during Dental Extraction from the baseline DBP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Secondary outcomes:
measure: Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP
timeFrame: Baseline, intraoperative, 5-min postoperative
measure: Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
measure: Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP
timeFrame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry & Pharmacy
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Ra'ed G Salma
role: PRINCIPAL_INVESTIGATOR
References: