Dental SedationNCT06780189
The Effects of Passive Smoking on Vital Signs, Anxiety, and Recovery Times in Children Undergoing Primary Tooth Extraction Treatment Under Sedation
A study testing Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking and Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking in people with Dental Sedation and Passive Smoking, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the effects of passive smoking on the vital parameters of children undergoing primary tooth extraction under sedation and to assess their anxiety levels throughout the process until discharge. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Sedation, Passive Smoking
- What is being tested?
- Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking and Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Jul 2024
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 4 and 6 years,
- Children classified as ASA 1,
- Children scoring 1 or 2 on the Frankl Behavior Scale,
- Children who are uncooperative for tooth extraction in the pediatric dentistry clinic,
- Children with an indication for primary tooth extraction,
- Parents/guardians of Turkish origin,
- Families who provide consent to participate in the study.
Who cannot join
- Children classified as ASA 2,3, 4, 5, or 6,
- Children scoring 3 or 4 on the Frankl Behavior Scale,
- Children younger than 4 years or older than 6 years,
- Children with acute apical abscess or cyst in the tooth scheduled for extraction,
- Children with an indication for permanent tooth extraction,
- Parents/guardians who use electronic cigarettes,
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- Parents/guardians undergoing nicotine replacement therapy,
- Parents/guardians who are not of Turkish origin,
- Families who do not wish to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ondokuz Mayıs University
Samsun, Atakum, 55200
Ondokuz Mayıs Üniversity Facult of Dentistry
Samsun, Atakum, 55200
About this study
Official title: Investigation of the Effects of Passive Smoking on Vital Signs, Motor Activity Levels, and Agitation Severity in Children Undergoing Tooth Extraction With Sedation
The aim of this clinical study is to evaluate the effects of passive smoking on the vital parameters of children undergoing primary tooth extraction under sedation and to assess their anxiety levels throughout the process until discharge.
The main questions it aims to answer are:
Read more
- Do the vital parameters of children who are passive smokers differ from those of non-passive smokers under sedation?
- Does the amount of smoking by family members influence the child's vital parameters?
- Does passive smoking affect recovery and awakening times following sedation?
- Does passive smoking impact the anxiety levels of children during the period leading up to discharge?
Participans:
- Children aged between 4 and 6 years,
- Children with an ASA score of 1,
- Children with a Frankl score of 4, 5, or 6,
- Children with an indication for primary tooth extraction,
- Parents/guardians who do not use electronic cigarettes.
Read the detailed description
Sample Size Calculation and Study Design
The sample size for this study was calculated based on the article by A.C. Torun et al. (1), titled "Sedative - Analgesic Activity of Remifentanil and Effect of Preoperative Anxiety on Perceived Pain in Outpatient Mandibular Third Molar Surgery." According to this reference, the minimum required sample size was determined to be 64, with a 95% confidence interval and 5% sensitivity. A total of 100 children were included in the study, of whom 36 were classified as non-passive smokers and 64 as passive smokers.
Inclusion Criteria
Participants included in the study must meet the following criteria:
- Children aged between 4 and 6 years,
- Children with an ASA physical status classification of 1,
- Children scoring 1 or 2 on the Frankl Behavior Scale,
- Children with an indication for primary tooth extraction.
Evaluation Parameters
- Assessment of Passive Smoking: Before the sedation procedure, parents/guardians will complete a questionnaire to determine the child's exposure to passive smoking.
- Monitoring of Vital Parameters: During the sedation procedure, all patients will be connected to a monitoring device to record their vital parameters.
- Assessment During and After Sedation:
- Richmond Agitation-Sedation Scale (RASS): This scale will be applied during the sedation procedure and for 5 minutes after the procedure is completed.
- Modified Aldrete Score (MASS): This scale will be used to measure recovery time.
- Pediatric Anesthesia Emergence Delirium (PAED) Scale: Starting from the moment the patient regains consciousness, scores will be recorded every 5 minutes.
Outcome Measurement
The data obtained from the questionnaires, monitoring devices, and applied scales will be analyzed to evaluate the effects of passive smoking on sedation outcomes, recovery times, and emergence behaviors. All measurements will be conducted with consistency and reliability.
- Conditions
- Dental Sedation, Passive Smoking
- Being tested
- Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking, Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking
- Keywords
- primary tooth, passive smoking, Tooth extraction, dental sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive SmokingProcedure or surgery
This study is designed to evaluate the relationship between passive smoking and the vital parameters of children undergoing deep sedation. Additionally, the study aims to comprehensively assess and document the entire treatment process from start to finish by using the RASS, MASS, and PAED scales for postoperative evaluation.
Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive SmokingProcedure or surgery
This study is designed to measure the differences in vital parameters of children undergoing deep sedation who are not exposed to passive cigarette smoke at home. Furthermore, the study aims to comprehensively evaluate and document the entire treatment process from start to finish using the RASS, MASS, and PAED scales for postoperative assessment.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with a daily cigarette consumption of fewer than 10 cigarettes. | Experimental | Not described Receives: Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who consume between 10 and 20 cigarettes per day | Experimental | Not described Receives: Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who consume more than 20 cigarettes per day. | Experimental | Not described Receives: Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who do not smoke | Active comparator | Not described Receives: Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation level
Oxygen saturation is a parameter that represents the percentage of oxygen bound to hemoglobin molecules in arterial blood. It is a critical physiological indicator that reflects whether sufficient oxygen is being transported to the body's tissues. Normal oxygen saturation levels typically range between 95% and 100%, while levels below this range are referred to as hypoxemia, indicating a deficiency in oxygen supply. Oxygen saturation is commonly measured using a non-invasive method known as pulse oximetry.
Measured: Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Apr 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental SedationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Buse Kaplan, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780189
- Sponsor's protocol ID
- 2023/387
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Kaplan EB, Avsar A. Impact of Passive Smoking on Vital Signs, Motor Activity, and Agitation in Children Undergoing Dental Extractions Under Sedation: A Short-Term Cohort Study. Healthcare (Basel). 2026 May 24;14(11):1451. doi: 10.3390/healthcare14111451.
PubMed 42278704
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Passive Smoking on Vital Signs, Motor Activity Levels, and Agitation Severity in Children Undergoing Tooth Extraction With Sedation
- ClinicalTrials.gov ID
- NCT06780189
- Acronym / sponsor ID
- 2023/387
- Conditions
- Dental Sedation, Passive Smoking
- Keywords
- primary tooth, passive smoking, Tooth extraction, dental sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 17 Jan 2025 (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 aim of this clinical study is to evaluate the effects of passive smoking on the vital parameters of children undergoing primary tooth extraction under sedation and to assess their anxiety levels throughout the process until discharge.
The main questions it aims to answer are:
- Do the vital parameters of children who are passive smokers differ from those of non-passive smokers under sedation?
- Does the amount of smoking by family members influence the child's vital parameters?
- Does passive smoking affect recovery and awakening times following sedation?
- Does passive smoking impact the anxiety levels of children during the period leading up to discharge?
Participans:
- Children aged between 4 and 6 years,
- Children with an ASA score of 1,
- Children with a Frankl score of 4, 5, or 6,
- Children with an indication for primary tooth extraction,
- Parents/guardians who do not use electronic cigarettes.
Detailed description
Sample Size Calculation and Study Design
The sample size for this study was calculated based on the article by A.C. Torun et al. (1), titled "Sedative - Analgesic Activity of Remifentanil and Effect of Preoperative Anxiety on Perceived Pain in Outpatient Mandibular Third Molar Surgery." According to this reference, the minimum required sample size was determined to be 64, with a 95% confidence interval and 5% sensitivity. A total of 100 children were included in the study, of whom 36 were classified as non-passive smokers and 64 as passive smokers.
Inclusion Criteria
Participants included in the study must meet the following criteria:
- Children aged between 4 and 6 years,
- Children with an ASA physical status classification of 1,
- Children scoring 1 or 2 on the Frankl Behavior Scale,
- Children with an indication for primary tooth extraction.
Evaluation Parameters
- Assessment of Passive Smoking: Before the sedation procedure, parents/guardians will complete a questionnaire to determine the child's exposure to passive smoking.
- Monitoring of Vital Parameters: During the sedation procedure, all patients will be connected to a monitoring device to record their vital parameters.
- Assessment During and After Sedation:
- Richmond Agitation-Sedation Scale (RASS): This scale will be applied during the sedation procedure and for 5 minutes after the procedure is completed.
- Modified Aldrete Score (MASS): This scale will be used to measure recovery time.
- Pediatric Anesthesia Emergence Delirium (PAED) Scale: Starting from the moment the patient regains consciousness, scores will be recorded every 5 minutes.
Outcome Measurement
The data obtained from the questionnaires, monitoring devices, and applied scales will be analyzed to evaluate the effects of passive smoking on sedation outcomes, recovery times, and emergence behaviors. All measurements will be conducted with consistency and reliability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individuals with a daily cigarette consumption of fewer than 10 cigarettes. | Experimental | Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who consume between 10 and 20 cigarettes per day | Experimental | Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who consume more than 20 cigarettes per day. | Experimental | Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking |
| Individuals who do not smoke | Active comparator | Procedure: Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged between 4 and 6 years,
- Children classified as ASA 1,
- Children scoring 1 or 2 on the Frankl Behavior Scale,
- Children who are uncooperative for tooth extraction in the pediatric dentistry clinic,
- Children with an indication for primary tooth extraction,
Key exclusion criteria (9 listed)
- Children classified as ASA 2,3, 4, 5, or 6,
- Children scoring 3 or 4 on the Frankl Behavior Scale,
- Children younger than 4 years or older than 6 years,
- Children with acute apical abscess or cyst in the tooth scheduled for extraction,
- Children with an indication for permanent tooth extraction,
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 |
|---|---|---|
| Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive SmokingThis study is designed to evaluate the relationship between passive smoking and the vital parameters of children undergoing deep sedation. Additionally, the study aims to comprehensively assess and document the entire treatment process from start to finish by using the RASS, MASS, and PAED scales for postoperative evaluation. | Procedure or surgery | Individuals who consume between 10 and 20 cigarettes per day, Individuals who consume more than 20 cigarettes per day., Individuals with a daily cigarette consumption of fewer than 10 cigarettes. |
| Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive SmokingThis study is designed to measure the differences in vital parameters of children undergoing deep sedation who are not exposed to passive cigarette smoke at home. Furthermore, the study aims to comprehensively evaluate and document the entire treatment process from start to finish using the RASS, MASS, and PAED scales for postoperative assessment. | Procedure or surgery | Individuals who do not smoke |
Primary outcome
Oxygen saturation level
Time frame: Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.
Oxygen saturation is a parameter that represents the percentage of oxygen bound to hemoglobin molecules in arterial blood. It is a critical physiological indicator that reflects whether sufficient oxygen is being transported to the body's tissues. Normal oxygen saturation levels typically range between 95% and 100%, while levels below this range are referred to as hypoxemia, indicating a deficiency in oxygen supply. Oxygen saturation is commonly measured using a non-invasive method known as pulse oximetry.
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 17 Jan 2025.
- Derived from this study: PubMed 42278704Kaplan EB, Avsar A. Impact of Passive Smoking on Vital Signs, Motor Activity, and Agitation in Children Undergoing Dental Extractions Under Sedation: A Short-Term Cohort Study. Healthcare (Basel). 2026 May 24;14(11):1451. doi: 10.3390/healthcare14111451.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Dental Sedation
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Dental Anxiety in Children, Child Behaviour
Enrolling by invitationObservational study
Treating Children With Extensive Dental Needs
Dental Caries, Tooth Extraction
RecruitingPhase 4
Sedation Versus Protective Stabilization for Pediatric Dental Treatment
Child Behavior, Dental Caries in Children
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking and Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking in people with Dental Sedation and Passive Smoking, run by Ondokuz Mayıs University at 2 sites 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 7 inclusion and 9 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Oxygen saturation level (time frame: Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780189, which also lists 1 linked publication.
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 17 Jan 2025.