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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in Turkey (Türkiye)

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 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.

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 groups in NCT06780189
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.

1 Apr 202431 Jul 2024

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.
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)

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