Dental AnxietyNCT03789942
Modification of Blood Pressure Levels and Oxygen Saturation in Patients Undergoing Conscious Sedation
A study testing Oral surgery in people with Dental Anxiety, run by Clinica Luis Ortiz at 1 site in Spain.
Trial summary
The objective is to compare the changes produced in cardiological and respiratory parameters in three groups of patients undergoing oral surgery. The first group was treated with local anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam, and a third subject under anesthesia… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Oral surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2019to 30 Mar 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of phobic patients
- Not having contraindications to be anesthetized or sedated, and
- Present an acceptable state of health (ASA I and ASA II).
Who cannot join
- Clinical conditions; ASA III, ASA IV and ASA V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Study of Cardiac and Respiratory Modifications Produced in Patients Undergoing Oral Surgery Through Local Anesthesia, Local Anesthesia and Oral Sedation With Midazolam, and Local Anesthesia Associated to Nitrous Oxide.
The objective is to compare the changes produced in cardiological and respiratory parameters in three groups of patients undergoing oral surgery. The first group was treated with local anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam, and a third subject under anesthesia local with inhalation sedation with nitrous oxide.
A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the University Master in Oral Surgery, Implantology and Periodontics of the University of León will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
They will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.
Read the detailed description
A total of 90 non-cooperative phobic adult patients will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
Initially, a complete health questionnaire will be filled out in all patients, and Partial Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the Systolic and Diastolic Blood Pressure before starting the procedure, records that will be repeated every 5 minutes during and until the end of it. The parameters will be recorded every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded exclusively at the beginning and at the end of the procedure.
- Conditions
- Dental Anxiety
- Being tested
- Oral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral surgeryProcedure or surgery
Oral surgery procedures
| Study group | Role | What they receive |
|---|---|---|
| 1. Local anaesthesia for oral surgery | Active comparator | Administration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure Receives: Procedure: Oral surgery |
| 2. Local anesthesia with Midazolam | Active comparator | Administration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once.
Oral surgery procedures Suturing End of procedure Receives: Procedure: Oral surgery |
| 3. Local anesthesia and sedation | Active comparator | Administration of 40mg. epinephrine once, and Inhalation Sedation by Nitrous Oxide / Oxygen.
Nitrous oxide sedation Oral surgery procedures Suturing End of procedure Reduce nitrous oxide concentration Receives: Procedure: Oral surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Oxygen Saturation (SpO2) change
Partial Oxygen Saturation (SpO2) change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
Respiratory Rate change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Forced Vital Capacity (FVC) change
Forced Vital Capacity (FVC) change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Forced Expiration Volume (FEV) change
Forced Expiration Volume (FEV) change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Maximum Expiratory Flow (PEF) change
Maximum Expiratory Flow (PEF) change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
Heart Rate change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change
Diastolic Blood Pressure change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
Systolic blood pressure change
Measured: From the beginning of the sedation until the end, assessed Up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start15 Feb 2019
- Primary completion20 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 90 patients will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure. Group 1, 30 patients treated by Oral Surgery procedures exclusively with Local Anesthesia. Group 2, 30 patients treated by procedures of Oral Surgery with Local Anesthesia and Oral Sedation with Midazolam. Group 3, 30 patients treated by Oral Surgery procedures with Local Anesthesia and Inhalation Sedation with a mixture of Nitrous Oxide / Oxygen.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Luis Ortiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ORTIZ CAMARERO, Principal investigator, ASISTANT PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789942
- Sponsor's protocol ID
- ÉTICA-ULE-011-2016
- Status last verified
- Dec 2018
- First submitted
- 14 Jul 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of Cardiac and Respiratory Modifications Produced in Patients Undergoing Oral Surgery Through Local Anesthesia, Local Anesthesia and Oral Sedation With Midazolam, and Local Anesthesia Associated to Nitrous Oxide.
- ClinicalTrials.gov ID
- NCT03789942
- Acronym / sponsor ID
- ÉTICA-ULE-011-2016
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Clinica Luis OrtizUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 31 Dec 2018 (actual)
- 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 objective is to compare the changes produced in cardiological and respiratory parameters in three groups of patients undergoing oral surgery. The first group was treated with local anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam, and a third subject under anesthesia local with inhalation sedation with nitrous oxide.
A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the University Master in Oral Surgery, Implantology and Periodontics of the University of León will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
They will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.
Detailed description
A total of 90 non-cooperative phobic adult patients will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
Initially, a complete health questionnaire will be filled out in all patients, and Partial Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the Systolic and Diastolic Blood Pressure before starting the procedure, records that will be repeated every 5 minutes during and until the end of it. The parameters will be recorded every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded exclusively at the beginning and at the end of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 90 patients will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure. Group 1, 30 patients treated by Oral Surgery procedures exclusively with Local Anesthesia. Group 2, 30 patients treated by procedures of Oral Surgery with Local Anesthesia and Oral Sedation with Midazolam. Group 3, 30 patients treated by Oral Surgery procedures with Local Anesthesia and Inhalation Sedation with a mixture of Nitrous Oxide / Oxygen.
| Arm | Type | Receives |
|---|---|---|
| 1. Local anaesthesia for oral surgery | Active comparator | Procedure: Oral surgeryAdministration of local anesthesia, 40mg.epinephrine once. Oral surgery procedures Suturing End of procedure |
| 2. Local anesthesia with Midazolam | Active comparator | Procedure: Oral surgeryAdministration of 40mg. epinephrine once, and Oral Sedation with Midazolam 0,5 mgr per kilo once. Oral surgery procedures Suturing End of procedure |
| 3. Local anesthesia and sedation | Active comparator | Procedure: Oral surgeryAdministration of 40mg. epinephrine once, and Inhalation Sedation by Nitrous Oxide / Oxygen. Nitrous oxide sedation Oral surgery procedures Suturing End of procedure Reduce nitrous oxide concentration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical Diagnosis of phobic patients
- Not having contraindications to be anesthetized or sedated, and
- Present an acceptable state of health (ASA I and ASA II).
Key exclusion criteria (1 listed)
- Clinical conditions; ASA III, ASA IV and ASA V
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 |
|---|---|---|
| Oral surgeryOral surgery procedures | Procedure or surgery | 1. Local anaesthesia for oral surgery, 2. Local anesthesia with Midazolam, 3. Local anesthesia and sedation |
Primary outcome
Partial Oxygen Saturation (SpO2) change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Partial Oxygen Saturation (SpO2) change
Respiratory Rate change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
Forced Vital Capacity (FVC) change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Forced Vital Capacity (FVC) change
Forced Expiration Volume (FEV) change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Forced Expiration Volume (FEV) change
Maximum Expiratory Flow (PEF) change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Maximum Expiratory Flow (PEF) change
Heart Rate change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
Diastolic Blood Pressure change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change
Systolic blood pressure change
Time frame: From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
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 2 Apr 2019.
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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.
ORTIZ CAMARERO principal investigator
ASISTANT PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral surgery in people with Dental Anxiety, run by Clinica Luis Ortiz at 1 site in Spain.
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 3 inclusion and 1 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 2 Apr 2019. 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 Spain. 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?
Partial Oxygen Saturation (SpO2) change (time frame: From the beginning of the sedation until the end, assessed Up to one hour). The study lists 8 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 2 Apr 2019.