NCT04388098

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

May 11, 2020

Last Update Submit

June 30, 2020

Conditions

Keywords

asthmachildrenoral health

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Asthmatic children

Asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.

Other: Diagnosis of caries experience and periodontal health

Non-asthmatic children

Non-asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition. Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.

Other: Diagnosis of caries experience and periodontal health

Interventions

Asthmatic childrenNon-asthmatic children

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

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

You may not qualify if:

  • Asthma diagnosis less than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

June 1, 2019

Last Updated

July 2, 2020

Record last verified: 2020-06