Anxiety, DentalPhase 3NCT05126459
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
A Phase 3 study testing Regimen 1, Regimen #2 and Regimen #3 in people with Anxiety, Dental and Dental Decay, run by Loma Linda University at 1 site in United States.
Trial summary
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Anxiety, Dental, Dental Decay
- What is being tested?
- Regimen 1, Regimen #2 and Regimen #3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 12 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.
- Age 3-7 years old, Healthy ( ASA-1 )
- No gender, race or ethnic restrictions.
- Reason for conscious oral sedation is situational anxiety in the dental operatory
Who cannot join
- Children with a history of acute illness
- History upper respiratory tract infection within two weeks of treatment
- Children taking any medication within the two weeks prior to scheduled dental treatment
- Sedation within the last six months
- Body mass index (BMI) greater than the 95th percentile for their age and sex
- Failing to drink the entire amount of sedation medications dispensed
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.
Read the detailed description
Inclusion criteria included patients of record who were scheduled to undergo oral sedation at Loma Linda University Pediatric Dentistry clinic for dental treatment. Children ages ranged from 3 to 6 years old with no medical issues, ASA-1. The reason for oral sedation was situational anxiety in the dental operatory. Exclusion criteria included children who presented with a history of: (1) acute illness; (2) upper respiratory tract infection within two weeks of treatment; (3) taking any medication within the two weeks prior to scheduled dental treatment; and (4) a body mass index (BMI) greater than the 95th percentile for their age and gender. A total sample of 60 healthy pediatric patients were included in this study with were no gender, race, or ethnic significant difference.
The included patients were randomly allocated into one of three sedation groups by drawing a concealed folded paper from an opaque randomization bag after obtaining parent consent. All papers that were used in the randomization had the same size and texture. The pediatric dental resident and attending faculty were informed with medication combination once randomized allocation had been made.
The study groups were as follows: Group 1 received Midazolam (0.5- 0.75 mg/kg), Meperidine (1.5-2.0 mg/kg), and Hydroxyzine (1.5- 2.0 mg/kg), Group 2 received Meperidine (1.5-2 mg/kg) and Hydroxyzine (1.5- 2.0 mg/kg). Group 3 received Midazolam (0.5- 0.75 mg/kg) and Hydroxyzine (1.5- 2mg/kg).
Clinical Procedure Calculations based on the child's weight of maximum local anesthetic delivery, oral sedation medication dosages, and reversal agents were completed prior to delivery of medication. The reversal agent used for benzodiazepines was Flumazenil, 0.01mg/Kg with a maximum of 0.2 mg/dose. While the reversal agent for Meperidine was Naloxone, calculated as 0.1 mg/Kg up to 2 mg.
After obtaining proper consents, all patients were placed in passive protective stabilization (Joey Board®, Joey Board, Queen Creek, AZ) in the event the child was to become uncooperative and to maintain patient stability during treatment, as coordination could be impaired. Nitrous oxide/Oxygen (N2O/O2) was used in all sedations and administered at a flow rate of four to six L/minute (30-50% N2O/ 10-50% O2) with 100% O2 given for five minutes pre- and postoperatively. All operating dentists followed standard sedation protocol at standard sedation protocol in Loma Linda University Pediatric Dentistry Clinic adapted from the American Academy of Pediatric Dentistry (AAPD) guidelines.8 Routine dental care was provided with local anesthesia with rubber dam or isolite® isolation. Xylocaine (2% lidocaine with 1:100,000 epinephrine) was used for local anesthesia in all cases and did not exceed 4 mg/kg lidocaine. Once AAPD discharge criteria8 were met, the patient was released to the parent. At that time, postoperative care instructions, including emergency contact numbers and recommendation for over-the-counter pain medications, if needed, were provided both verbally and in written form.
The dentist performing each sedation was asked to complete a detailed questionnaire that provided details about the patient's behavior from the time of drug administration to the time of discharge (Survey 1). In addition, parents received two telephone interviews regarding events that occurred after the sedation session. An investigator conducted all phone interviews. These phone interviews took place at eight hours (Survey 2) and 24 hours (Survey 3) after discharge.
For all three of the surveys, questions were designed to elucidate patient physical signs and/or behaviors that fell into the following categories: (1) sleep disturbances; (2) gastrointestinal side effects; (3) non-aggressive behavior changes; (4) residual central nervous system alterations; (5) respiratory depression; (6) musculoskeletal effects; (7) physical reactions; (8) existence of a paradoxical reaction; and (9) amnesic effects. Information on the pre-sedation cooperation level and overall effectiveness of the sedation (rated as ineffective, effective, very effective, or overly sedated) were obtained from the procedural sedation record (adopted from AAPD) corresponding to each case.
- Conditions
- Anxiety, Dental, Dental Decay
- Being tested
- Regimen 1, Regimen #2, Regimen #3
- Keywords
- Pediatric, Dental
- Medical subject headings
- Anxiety Disorders, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regimen 1Combination product
Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.
Regimen #2Combination product
Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.
Regimen #3Combination product
Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Active comparator | Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) Receives: Combination Product: Regimen 1 |
| Regimen 2 | Experimental | Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) - Receives: Combination Product: Regimen #2 |
| Regimen 3 | Experimental | Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) Receives: Combination Product: Regimen #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.
Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge Musculoskeletal system reaction during sedation scale: This is the result for Musculoskeletal related questions, it is a sum of 3 yes or no questions. (minimum=0, maximum=3) The higher the worse.
Measured: during sedation
Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.
Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.
Musculoskeletal system reaction at 8 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.
Measured: Change 8 (eight) hours post oral sedation medication administration
Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.
Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.
Musculoskeletal system reaction at 24 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.
Measured: Change between 24 (twenty-four) hours post oral sedation
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation
Compare the number and type of adverse effect related gastrointestinal reactions.
Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.
GI effect for during sedation score; This is a summary of 3 yes/no questions, Minimum = 0 Maximum =3, the higher means more GI reactions, the worse outcome
Measured: During sedation
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation
Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.
GI effect 8 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome.
Measured: 8 hours after sedation
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation
Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.
Long term effect for 24 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome
Measured: 24 hours after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start14 Feb 2022
- Primary completion11 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Wei Chen, DDS, MS, PhD, Loma Linda University
- Investigators
- Jung-Wei Chen, DDS,MS,PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126459
- Sponsor's protocol ID
- 5190213
- Status last verified
- Sep 2024
- First submitted
- 8 Nov 2021
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT05126459
- Acronym / sponsor ID
- 5190213
- Conditions
- Anxiety, Dental, Dental Decay
- Keywords
- Pediatric, Dental
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.
Detailed description
Inclusion criteria included patients of record who were scheduled to undergo oral sedation at Loma Linda University Pediatric Dentistry clinic for dental treatment. Children ages ranged from 3 to 6 years old with no medical issues, ASA-1. The reason for oral sedation was situational anxiety in the dental operatory. Exclusion criteria included children who presented with a history of: (1) acute illness; (2) upper respiratory tract infection within two weeks of treatment; (3) taking any medication within the two weeks prior to scheduled dental treatment; and (4) a body mass index (BMI) greater than the 95th percentile for their age and gender. A total sample of 60 healthy pediatric patients were included in this study with were no gender, race, or ethnic significant difference.
The included patients were randomly allocated into one of three sedation groups by drawing a concealed folded paper from an opaque randomization bag after obtaining parent consent. All papers that were used in the randomization had the same size and texture. The pediatric dental resident and attending faculty were informed with medication combination once randomized allocation had been made.
The study groups were as follows: Group 1 received Midazolam (0.5- 0.75 mg/kg), Meperidine (1.5-2.0 mg/kg), and Hydroxyzine (1.5- 2.0 mg/kg), Group 2 received Meperidine (1.5-2 mg/kg) and Hydroxyzine (1.5- 2.0 mg/kg). Group 3 received Midazolam (0.5- 0.75 mg/kg) and Hydroxyzine (1.5- 2mg/kg).
Clinical Procedure Calculations based on the child's weight of maximum local anesthetic delivery, oral sedation medication dosages, and reversal agents were completed prior to delivery of medication. The reversal agent used for benzodiazepines was Flumazenil, 0.01mg/Kg with a maximum of 0.2 mg/dose. While the reversal agent for Meperidine was Naloxone, calculated as 0.1 mg/Kg up to 2 mg.
After obtaining proper consents, all patients were placed in passive protective stabilization (Joey Board®, Joey Board, Queen Creek, AZ) in the event the child was to become uncooperative and to maintain patient stability during treatment, as coordination could be impaired. Nitrous oxide/Oxygen (N2O/O2) was used in all sedations and administered at a flow rate of four to six L/minute (30-50% N2O/ 10-50% O2) with 100% O2 given for five minutes pre- and postoperatively. All operating dentists followed standard sedation protocol at standard sedation protocol in Loma Linda University Pediatric Dentistry Clinic adapted from the American Academy of Pediatric Dentistry (AAPD) guidelines.8 Routine dental care was provided with local anesthesia with rubber dam or isolite® isolation. Xylocaine (2% lidocaine with 1:100,000 epinephrine) was used for local anesthesia in all cases and did not exceed 4 mg/kg lidocaine. Once AAPD discharge criteria8 were met, the patient was released to the parent. At that time, postoperative care instructions, including emergency contact numbers and recommendation for over-the-counter pain medications, if needed, were provided both verbally and in written form.
The dentist performing each sedation was asked to complete a detailed questionnaire that provided details about the patient's behavior from the time of drug administration to the time of discharge (Survey 1). In addition, parents received two telephone interviews regarding events that occurred after the sedation session. An investigator conducted all phone interviews. These phone interviews took place at eight hours (Survey 2) and 24 hours (Survey 3) after discharge.
For all three of the surveys, questions were designed to elucidate patient physical signs and/or behaviors that fell into the following categories: (1) sleep disturbances; (2) gastrointestinal side effects; (3) non-aggressive behavior changes; (4) residual central nervous system alterations; (5) respiratory depression; (6) musculoskeletal effects; (7) physical reactions; (8) existence of a paradoxical reaction; and (9) amnesic effects. Information on the pre-sedation cooperation level and overall effectiveness of the sedation (rated as ineffective, effective, very effective, or overly sedated) were obtained from the procedural sedation record (adopted from AAPD) corresponding to each case.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Active comparator | Combination Product: Regimen 1Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) |
| Regimen 2 | Experimental | Combination Product: Regimen #2Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) - |
| Regimen 3 | Experimental | Combination Product: Regimen #3Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.
- Age 3-7 years old, Healthy ( ASA-1 )
- No gender, race or ethnic restrictions.
- Reason for conscious oral sedation is situational anxiety in the dental operatory
Key exclusion criteria (6 listed)
- Children with a history of acute illness
- History upper respiratory tract infection within two weeks of treatment
- Children taking any medication within the two weeks prior to scheduled dental treatment
- Sedation within the last six months
- Body mass index (BMI) greater than the 95th percentile for their age and sex
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 |
|---|---|---|
| Regimen 1Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation. | Combination product | Regimen 1 |
| Regimen #2Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation. | Combination product | Regimen 2 |
| Regimen #3Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation. | Combination product | Regimen 3 |
Primary outcome
Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation
Time frame: during sedation
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge Musculoskeletal system reaction during sedation scale: This is the result for Musculoskeletal related questions, it is a sum of 3 yes or no questions. (minimum=0, maximum=3) The higher the worse.
Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours
Time frame: Change 8 (eight) hours post oral sedation medication administration
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. Musculoskeletal system reaction at 8 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.
Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation
Time frame: Change between 24 (twenty-four) hours post oral sedation
Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. Musculoskeletal system reaction at 24 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation
Time frame: During sedation
Compare the number and type of adverse effect related gastrointestinal reactions. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. GI effect for during sedation score; This is a summary of 3 yes/no questions, Minimum = 0 Maximum =3, the higher means more GI reactions, the worse outcome
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation
Time frame: 8 hours after sedation
Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge. GI effect 8 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome.
Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation
Time frame: 24 hours after sedation
Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge. Long term effect for 24 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jung-Wei Chen, DDS,MS,PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regimen 1, Regimen #2 and Regimen #3 in people with Anxiety, Dental and Dental Decay, run by Loma Linda University at 1 site in United States.
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 4 inclusion and 6 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 Oct 2024. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation (time frame: during sedation). The study lists 6 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 Oct 2024.