Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-02-10
2017-12-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
SCREENING
DOUBLE
Study Groups
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Control Group (T0)
The supragingival scaling without LA
Scaling without LA
The patient will undergo a supragingival scaling procedure without local anesthesia
Test Group 1 (T1)
The simple restoration under LA
Simple restoration under LA
The patient will undergo a simple dental restoration procedure under local anesthesia
Test Group 2 (T2)
The simple exodontia under LA
Simple exodontia under LA
The patient will undergo a simple dental extraction procedure under local anesthesia
Interventions
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Scaling without LA
The patient will undergo a supragingival scaling procedure without local anesthesia
Simple restoration under LA
The patient will undergo a simple dental restoration procedure under local anesthesia
Simple exodontia under LA
The patient will undergo a simple dental extraction procedure under local anesthesia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Riyadh Colleges of Dentistry and Pharmacy
OTHER
Responsible Party
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Ra'ed Salma
Assistant Professor Oral and Maxillofacial Surgery
Principal Investigators
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Ra'ed G Salma
Role: PRINCIPAL_INVESTIGATOR
Riyadh Colleges of Dentistry and Pharmacy
Locations
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Riyadh Colleges of Dentistry & Pharmacy
Riyadh, , Saudi Arabia
Countries
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Other Identifiers
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FRP/2016/43
Identifier Type: -
Identifier Source: org_study_id
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