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

NCT06780189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-17

No results posted yet for this study

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. Do the vital parameters of children who are passive smokers differ from those of non-passive smokers under sedation?
2. Does the amount of smoking by family members influence the child's vital parameters?
3. Does passive smoking affect recovery and awakening times following sedation?
4. 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.

Conditions

  • Dental Sedation
  • Passive Smoking

Interventions

PROCEDURE

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

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.

PROCEDURE

Tooth Extraction and Post-Procedure Monitoring Under Sedation in Children Not Exposed to Passive Smoking

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.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780189 on ClinicalTrials.gov