The Effects of Passive Smoking on Vital Signs, Anxiety, and Recovery Times in Children Undergoing Primary Tooth Extraction Treatment Under Sedation

NCT06780189 | Completed

• 1 other identifier: 2023/387
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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:

• 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.

Conditions

Dental Sedation; Passive Smoking

Keywords

primary tooth; passive smoking; Tooth extraction; dental sedation

Outcome Measures

Primary Outcomes (1)

• 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.

  Start Time: Before the administration of sedative drugs. End Time: At the completion of the tooth extraction procedure under deep sedation.

Study Arms (4)

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

Interventions

Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Exposed to Passive Smoking PROCEDURE

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.

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 Smoking PROCEDURE

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.

Individuals who do not smoke

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Parents/guardians undergoing nicotine replacement therapy,
• Parents/guardians who are not of Turkish origin,
• Families who do not wish to participate in the study.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

Ondokuz Mayıs University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Ondokuz Mayıs Üniversity Facult of Dentistry

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: April 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (2)