Vital Signs Changes During Dental Procedures

NCT ID: NCT02788890

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2017-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vital Signs Changes During Dental Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
The care provider was not aware of study objectives. The outcomes assessor was not involved in the data collection.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group (T0)

The supragingival scaling without LA

Group Type ACTIVE_COMPARATOR

Scaling without LA

Intervention Type PROCEDURE

The patient will undergo a supragingival scaling procedure without local anesthesia

Test Group 1 (T1)

The simple restoration under LA

Group Type EXPERIMENTAL

Simple restoration under LA

Intervention Type PROCEDURE

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

Test Group 2 (T2)

The simple exodontia under LA

Group Type EXPERIMENTAL

Simple exodontia under LA

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scaling without LA

The patient will undergo a supragingival scaling procedure without local anesthesia

Intervention Type PROCEDURE

Simple restoration under LA

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

Intervention Type PROCEDURE

Simple exodontia under LA

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ra'ed Salma

Assistant Professor Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ra'ed G Salma

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riyadh Colleges of Dentistry & Pharmacy

Riyadh, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FRP/2016/43

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.