Dental Anxiety
Conditions
Brief 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 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.
Interventions
PROCEDUREOral surgery
Oral surgery procedures
Sponsors
Clinica Luis Ortiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Clinical conditions; ASA III, ASA IV and ASA V
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Oxygen Saturation (SpO2) change | From the beginning of the sedation until the end, assessed Up to one hour | Partial Oxygen Saturation (SpO2) change |
| Respiratory Rate change | From the beginning of the sedation until the end, assessed Up to one hour | Respiratory Rate change |
| Forced Vital Capacity (FVC) change | From the beginning of the sedation until the end, assessed Up to one hour | Forced Vital Capacity (FVC) change |
| Forced Expiration Volume (FEV) change | From the beginning of the sedation until the end, assessed Up to one hour | Forced Expiration Volume (FEV) change |
| Maximum Expiratory Flow (PEF) change | From the beginning of the sedation until the end, assessed Up to one hour | Maximum Expiratory Flow (PEF) change |
| Heart Rate change | From the beginning of the sedation until the end, assessed Up to one hour | Heart Rate change |
| Diastolic Blood Pressure change | From the beginning of the sedation until the end, assessed Up to one hour | Diastolic Blood Pressure change |
| Systolic blood pressure change | From the beginning of the sedation until the end, assessed Up to one hour | Systolic blood pressure change |
Countries
Spain
Outcome results
None listed