Oral Health Status of Asthmatic Children

Asthma in Children Clinical Trial

Official title:

Oral Health Status of Asthmatic Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388098
• Other study ID #: 2017/210
• Status: Completed
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2020
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Diagnosis of caries experience and periodontal health

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health status	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.	During examination 1 day
Primary	salivary flow rate -Salivary characteristics	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.	5 minutes after saliva collection
Primary	salivary pH - Salivary characteristics	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.	5 minutes after saliva collection
Primary	buffering capacity - Salivary characteristics	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.	5 minutes after saliva collection