Vital Signs Changes During Dental Procedures

Riyadh Colleges of Dentistry and Pharmacy

Status: Completed

Conditions: Vital Signs Changes During Dental Procedures

Treatments: Procedure: Simple exodontia under LA; Procedure: Scaling without LA; Procedure: Simple restoration under LA

Study type: Interventional

Funder types: Other

Identifiers

NCT02788890

FRP/2016/43

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 3 patient groups

Control Group (T0)

Active Comparator group

Description:

The supragingival scaling without LA

Treatment:

Procedure: Scaling without LA

Test Group 1 (T1)

Experimental group

Description:

The simple restoration under LA

Treatment:

Procedure: Simple restoration under LA

Test Group 2 (T2)

Experimental group

Description:

The simple exodontia under LA

Treatment:

Procedure: Simple exodontia under LA