Completed

Passive Smoking Effects on Sedation in Children Undergoing Tooth Extraction

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What is 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

Procedure
Who is being recruted

From 4 to 6 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorOndokuz Mayıs University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2024

Actual date on which the first participant was enrolled.

This study is focused on understanding the impact of passive smoking on children aged 4 to 6 years who are undergoing tooth extractions with sedation. The research aims to evaluate how exposure to secondhand smoke affects vital signs, levels of movement, and agitation during and after dental procedures. By involving 100 children, the study is designed to compare those exposed to passive smoking with those who are not, helping to reveal any differences in sedation outcomes and recovery. This research is important because it seeks to improve the understanding of how environmental factors like passive smoking can affect children's health and recovery during dental procedures. During the study, participants undergo tooth extractions while being sedated, with their vital signs closely monitored throughout the procedure. Parents or guardians fill out a questionnaire to assess the child's exposure to passive smoking. The study uses various assessment tools, including the Richmond Agitation-Sedation Scale to measure agitation, the Modified Aldrete Score to evaluate recovery time, and the Pediatric Anesthesia Emergence Delirium Scale to assess behavior as the child wakes up. These measurements help to determine the influence of passive smoking on sedation effectiveness and recovery, potentially highlighting risks associated with secondhand smoke exposure in children during medical treatments.

Official TitleInvestigation of the Effects of Passive Smoking on Vital Signs, Motor Activity Levels, and Agitation Severity in Children Undergoing Tooth Extraction With Sedation
NCT06780189
Principal SponsorOndokuz Mayıs University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
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,

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9 exclusion criteria prevent from participating
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,

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)Open Ondokuz Mayıs University in Google Maps
Suspended

Ondokuz Mayıs Üniversity Facult of Dentistry

Samsun, Turkey (Türkiye)
Completed2 Study Centers