Vital Signs Changes During Dental ProceduresNCT02788890
Vital Signs Changes During Dental Procedures
A study testing Scaling without LA, Simple restoration under LA and Simple exodontia under LA in people with Vital Signs Changes During Dental Procedures, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Signs Changes During Dental Procedures
- What is being tested?
- Scaling without LA, Simple restoration under LA and Simple exodontia under LA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Vital Signs Changes During Different Dental Procedures in Otherwise Healthy Adult Patients.
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.
- Being tested
- Scaling without LA, Simple restoration under LA, Simple exodontia under LA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling without LAProcedure or surgery
The patient will undergo a supragingival scaling procedure without local anesthesia
Simple restoration under LAProcedure or surgery
The patient will undergo a simple dental restoration procedure under local anesthesia
Simple exodontia under LAProcedure or surgery
The patient will undergo a simple dental extraction procedure under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control Group (T0) | Active comparator | The supragingival scaling without LA Receives: Procedure: Scaling without LA |
| Test Group 1 (T1) | Experimental | The simple restoration under LA Receives: Procedure: Simple restoration under LA |
| Test Group 2 (T2) | Experimental | The simple exodontia under LA Receives: Procedure: Simple exodontia under LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT
Body temperature measured in Celsius using infrared non-contact digital thermometer
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Secondary outcomes (6)
Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg
Measured: Baseline, intraoperative, 5-min postoperative
Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg
Measured: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The PP is then calculated as the systolic and diastolic blood pressure difference and recorded in mmHg
Measured: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation:
MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg
Measured: Baseline, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation:
MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg
Measured: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP
The blood pressure BP will be measured utilizing the NIBP (noninvasive blood pressure) measurement tool attached to an ambulatory digital monitor. The MAP is then calculated using the following equation:
MAP= (Systolic BP + 2*Diastolic BP)/3 And recorded in mmHg
Measured: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start10 Feb 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Signs Changes During Dental ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ra'ed Salma, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Ra'ed G Salma, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788890
- Sponsor's protocol ID
- FRP/2016/43
- Status last verified
- Dec 2017
- First submitted
- 23 May 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Changes During Different Dental Procedures in Otherwise Healthy Adult Patients.
- ClinicalTrials.gov ID
- NCT02788890
- Acronym / sponsor ID
- FRP/2016/43
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (T0) | Active comparator | Procedure: Scaling without LAThe supragingival scaling without LA |
| Test Group 1 (T1) | Experimental | Procedure: Simple restoration under LAThe simple restoration under LA |
| Test Group 2 (T2) | Experimental | Procedure: Simple exodontia under LAThe simple exodontia under LA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling without LAThe patient will undergo a supragingival scaling procedure without local anesthesia | Procedure or surgery | Control Group (T0) |
| Simple restoration under LAThe patient will undergo a simple dental restoration procedure under local anesthesia | Procedure or surgery | Test Group 1 (T1) |
| Simple exodontia under LAThe patient will undergo a simple dental extraction procedure under local anesthesia | Procedure or surgery | Test Group 2 (T2) |
Primary outcome
Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT
Time frame: Baseline, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change in Body Temperature (BT) during Operative Procedure from the baseline BT
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change from baseline Body Temperature (BT) during Dental Extraction from the baseline BT
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Body temperature measured in Celsius using infrared non-contact digital thermometer
Change in Respiratory Rate (RR) during Periodontal Therapy from the baseline RR
Time frame: Baseline, intraoperative, 5-min postoperative
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)
Change in Respiratory Rate (RR) during Operative Procedure from the baseline RR
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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)
Change in Respiratory Rate (RR) during Dental Extraction from the baseline RR
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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)
Change in Heart Rate (HR) during Periodontal Therapy from the baseline HR
Time frame: Baseline, intraoperative, 5-min postoperative
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
Change in Heart Rate (HR) during Operative Procedure from the baseline HR
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Heart Rate (HR) during Dental Extraction from the baseline HR
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Periodontal Therapy from the baseline SpO2
Time frame: Baseline, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Operative Procedure from the baseline SpO2
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Peripheral Oxygen Saturation (SpO2) during Dental Extraction from the baseline SpO2
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Periodontal Therapy from the baseline SBP
Time frame: Baseline, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Operative Procedure from the baseline SBP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Systolic Blood Pressure (SBP) during Dental Extraction from the baseline SBP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Periodontal Therapy from the baseline DBP
Time frame: Baseline, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Operative Procedure from the baseline DBP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
Change in Diastolic Blood Pressure (DBP) during Dental Extraction from the baseline DBP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
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
6 secondary outcomes
Change in Pulse Pressure (PP) during Periodontal Therapy from the baseline PP
Time frame: Baseline, intraoperative, 5-min postoperative
Change in Pulse Pressure (PP) during Operative Procedure from the baseline PP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Pulse Pressure (PP) during Dental Extraction from the baseline PP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Periodontal Therapy from the baseline MAP
Time frame: Baseline, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Operative Procedure from the baseline MAP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Change in Mean Arterial Pressure (MAP) during Dental Extraction from the baseline MAP
Time frame: Baseline, during anesthesia injection, intraoperative, 5-min postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ra'ed G Salma principal investigator
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling without LA, Simple restoration under LA and Simple exodontia under LA in people with Vital Signs Changes During Dental Procedures, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Temperature (BT) during Periodontal Therapy from the baseline BT (time frame: Baseline, intraoperative, 5-min postoperative). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.