Anxiety PostoperativeNCT04623970
Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients
A study testing Dental Treatment in people with Anxiety Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time… Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Postoperative
- What is being tested?
- Dental Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2018to 5 Oct 2020
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients age between 3-7 years old
- Having no systemic condition and ASA 1 healty status
- Having high dental anxiety
- Having no dental treatment under the sedation or general anesthesia before
- Having no dental treatment before
Who cannot join
- Having obstructed nasal passages, raised intracranial or intraocular pressure, allergy
- Using any drug which effected saliva construction
- Having enough saliva for saliva cortisol evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi
The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.
Read the detailed description
This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.
- Conditions
- Anxiety Postoperative
- Being tested
- Dental Treatment
- Keywords
- Dental anxiety, Deep Sedation, Ketofol, Propofol, Salivary Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental TreatmentProcedure or surgery
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
| Study group | Role | What they receive |
|---|---|---|
| Propofol sedation group | Experimental | Patients in this experimental group received propofol sedation agent. Receives: Procedure: Dental Treatment |
| Ketofol 1:3 sedation group | Experimental | Patients in this experimental group received ketofol sedation agent as a 1:3 mixture. Receives: Procedure: Dental Treatment |
| Ketofol 1:4 sedation group | Experimental | Patients in this experimental group received ketofol sedation agent as a 1:4 mixture. Receives: Procedure: Dental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety (subjective)
Units on a Scale (Patient's dental anxiety level was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for dental anxiety.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as no anxiety. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Measured: through study completion, an average of 12 months
Dental anxiety (objective)
Units on Saliva cortisol levels (Dental anxiety was evaluated with Enzyme-linked immunosorbent assay after treatment.The patients were measured from 0 to 200 nmol/L for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-28 nmol/L'' are considered as better outcome. Patients who were have these scores described no dental anxiety for deep sedation. The worst outcome is considered as the anxious patients have ">28 nmol/L ". Each value range for each time interval evaluated as count of patient and presented as percentage.)
Measured: through study completion, an average of 12 months
Depth of sedation
Units on a Scale (Depth of sedation was evaluated with Ramsay Sedation Scale during the sedation. Observer signed from 0 to 5 score for depth of sedation during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "4-5" scores are considered as better outcome. Patients who were signed these scores described as sedated patients for dental treatment. The worst outcome is considered as the patients signed "0-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Measured: through study completion, an average of 12 months
Postperative complications
Units on a Scale ( Postoperative complications were evaluated with a form which was included absence or presence of agitation, hypersalivation, nausea-vomiting and double vision. Observer signed absence or presence for each complications after the treatment.The data were collected and statistically analysed using by the numerical data)
Measured: through study completion, an average of 12 months
Perioperative complications
Units on a Scale (Perioperative complications were evaluated with a form which was included absence or presence of local injection pain, cough, saturation drop and spontaneous movement. Observer signed absence or presence for each perioperative complications during the deep sedation.The data were collected and statistically analysed using by the numerical data)
Measured: through study completion, an average of 12 months
Secondary outcomes (3)
Heart Rate
Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation)
Measured: through study completion, an average of 12 months
Systolic and diastolic arterial pressure
Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation)
Measured: through study completion, an average of 12 months
Oxygen saturation
Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation)
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start28 Nov 2018
- Primary completion23 Jan 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety PostoperativeStudies of the same condition, open and under way.
- More trials run by Cukurova 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, volkan Ciftci, Cukurova University
- Investigators
- volkan Ciftci, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623970
- Sponsor's protocol ID
- 82/2
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi
- ClinicalTrials.gov ID
- NCT04623970
- Acronym / sponsor ID
- 82/2
- Conditions
- Anxiety Postoperative
- Keywords
- Dental anxiety, Deep Sedation, Ketofol, Propofol, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 10 Nov 2020 (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 aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.
Detailed description
This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol sedation group | Experimental | Procedure: Dental TreatmentPatients in this experimental group received propofol sedation agent. |
| Ketofol 1:3 sedation group | Experimental | Procedure: Dental TreatmentPatients in this experimental group received ketofol sedation agent as a 1:3 mixture. |
| Ketofol 1:4 sedation group | Experimental | Procedure: Dental TreatmentPatients in this experimental group received ketofol sedation agent as a 1:4 mixture. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients age between 3-7 years old
- Having no systemic condition and ASA 1 healty status
- Having high dental anxiety
- Having no dental treatment under the sedation or general anesthesia before
- Having no dental treatment before
Key exclusion criteria (3 listed)
- Having obstructed nasal passages, raised intracranial or intraocular pressure, allergy
- Using any drug which effected saliva construction
- Having enough saliva for saliva cortisol evaluation
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 |
|---|---|---|
| Dental TreatmentComprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation | Procedure or surgery | Ketofol 1:3 sedation group, Ketofol 1:4 sedation group, Propofol sedation group |
Primary outcome
Dental anxiety (subjective)
Time frame: through study completion, an average of 12 months
Units on a Scale (Patient's dental anxiety level was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for dental anxiety.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as no anxiety. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Dental anxiety (objective)
Time frame: through study completion, an average of 12 months
Units on Saliva cortisol levels (Dental anxiety was evaluated with Enzyme-linked immunosorbent assay after treatment.The patients were measured from 0 to 200 nmol/L for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-28 nmol/L'' are considered as better outcome. Patients who were have these scores described no dental anxiety for deep sedation. The worst outcome is considered as the anxious patients have ">28 nmol/L ". Each value range for each time interval evaluated as count of patient and presented as percentage.)
Depth of sedation
Time frame: through study completion, an average of 12 months
Units on a Scale (Depth of sedation was evaluated with Ramsay Sedation Scale during the sedation. Observer signed from 0 to 5 score for depth of sedation during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "4-5" scores are considered as better outcome. Patients who were signed these scores described as sedated patients for dental treatment. The worst outcome is considered as the patients signed "0-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Postperative complications
Time frame: through study completion, an average of 12 months
Units on a Scale ( Postoperative complications were evaluated with a form which was included absence or presence of agitation, hypersalivation, nausea-vomiting and double vision. Observer signed absence or presence for each complications after the treatment.The data were collected and statistically analysed using by the numerical data)
Perioperative complications
Time frame: through study completion, an average of 12 months
Units on a Scale (Perioperative complications were evaluated with a form which was included absence or presence of local injection pain, cough, saturation drop and spontaneous movement. Observer signed absence or presence for each perioperative complications during the deep sedation.The data were collected and statistically analysed using by the numerical data)
3 secondary outcomes
Heart Rate
Time frame: through study completion, an average of 12 months
Systolic and diastolic arterial pressure
Time frame: through study completion, an average of 12 months
Oxygen saturation
Time frame: through study completion, an average of 12 months
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 13 Nov 2020.
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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.
volkan Ciftci study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Treatment in people with Anxiety Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 13 Nov 2020. 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 Turkey (Türkiye). 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?
Dental anxiety (subjective) (time frame: through study completion, an average of 12 months). The study lists 5 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 13 Nov 2020.