Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03789942
Other study ID # ÉTICA-ULE-011-2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date March 30, 2019

Study information

Verified date December 2018
Source Clinica Luis Ortiz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 30, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Oral surgery
Oral surgery procedures

Locations

Country Name City State
Spain Clinica Luis Ortiz Burgos

Sponsors (1)

Lead Sponsor Collaborator
Clinica Luis Ortiz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Partial Oxygen Saturation (SpO2) change Partial Oxygen Saturation (SpO2) change From the beginning of the sedation until the end, assessed Up to one hour
Primary Respiratory Rate change Respiratory Rate change From the beginning of the sedation until the end, assessed Up to one hour
Primary Forced Vital Capacity (FVC) change Forced Vital Capacity (FVC) change From the beginning of the sedation until the end, assessed Up to one hour
Primary Forced Expiration Volume (FEV) change Forced Expiration Volume (FEV) change From the beginning of the sedation until the end, assessed Up to one hour
Primary Maximum Expiratory Flow (PEF) change Maximum Expiratory Flow (PEF) change From the beginning of the sedation until the end, assessed Up to one hour
Primary Heart Rate change Heart Rate change From the beginning of the sedation until the end, assessed Up to one hour
Primary Diastolic Blood Pressure change Diastolic Blood Pressure change From the beginning of the sedation until the end, assessed Up to one hour
Primary Systolic blood pressure change Systolic blood pressure change From the beginning of the sedation until the end, assessed Up to one hour
See also
  Status Clinical Trial Phase
Completed NCT06385314 - A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
Completed NCT04308005 - Drawing as a Measurement of Dental Anxiety
Completed NCT01908127 - Efficacy of Film Modelling in Paediatric Dentistry N/A
Completed NCT00695630 - Flumazenil Reversal of Oral Triazolam Phase 1/Phase 2
Completed NCT05759286 - A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient N/A
Completed NCT04234737 - Efficacy of Hypnotherapy in Children With Dental Anxiety N/A
Completed NCT03838081 - Evaluation on the Anxiety of Third Molar Extraction N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Not yet recruiting NCT04924452 - Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients N/A
Completed NCT03722771 - Influence of Lavender Oil on Vital Signs in Oral Surgery Patients N/A
Completed NCT03596255 - Clinical Estimation of Dental Anxiety
Completed NCT05038540 - The Effect of Virtual Reality Glasses on Dental Anxiety Control N/A
Completed NCT03324347 - Dog-Assisted Therapy in Dentistry N/A
Not yet recruiting NCT06139640 - The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children N/A
Completed NCT02591797 - Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children N/A
Completed NCT02588079 - Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety N/A
Not yet recruiting NCT00355693 - Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients Phase 4
Recruiting NCT06243705 - Effectiveness of Robot-pets in Reducing Dental Anxiety in Children N/A
Recruiting NCT06058533 - Pre-Visit Positive Imagery in Reducing Dental Anxiety N/A
Completed NCT03993080 - Virtual Reality Relaxation to Decrease Dental Anxiety N/A