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Completed

NCT Number: NCT04388098

Oral Health Status of Asthmatic Children

This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents.

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Key information

About this study

A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control). All the children were clinically examined to assess their dental caries experience and periodontal health condition. A trained and calibrated examiner (kappa = 0.95) performed the dental caries examination according to World Health Organization (WHO) criteria. Dental caries status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. Periodontal health was assessed by gingival index [GI] and plaque index(PI). An interview was conducted with parents/guardians and a structured questionnaire was employed to parents in addition to medical records. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 7-16
  • Asthma diagnosis
  • Asthma treatment for at least 1 year
  • Under asthma medication
  • Healthy controls without any systemic condition

Exclusion criteria

  • Asthma diagnosis less than a year

Treatment and study plan

Diagnosis of caries experience and periodontal health

Other

Primary outcomes

  1. Oral health status

    Time frame: During examination 1 day

    Caries experience of asthmatic and non-asthmatic children was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices. The gingival index (GI) was used to assess the gingival condition according to the criteria of Loe and Silness as follows: no gingival inflammation (<0.1), mild inflammation (0.1-1.0), moderate inflammation (1.1-1.9), and severe inflammation in case of marked gingival redness and edema with spontaneous bleeding and ulceration (2.0-3.0) Plaque index(PI) was used to assess the amount of dental plaque.The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.

  2. salivary flow rate -Salivary characteristics

    Time frame: 5 minutes after saliva collection

    Stimulated salivary samples were collected and assessed for salivary flow rate. Saliva check buffer kit was used for the measurements according to instructions described on the user guide.

  3. salivary pH - Salivary characteristics

    Time frame: 5 minutes after saliva collection

    Stimulated salivary samples were collected and assessed for salivary pH GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.

  4. buffering capacity - Salivary characteristics

    Time frame: 5 minutes after saliva collection

    Stimulated salivary samples were collected and assessed for buffering capacity. GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Oral Health Status of Asthmatic Children and Adolescents

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 14, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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