Clinical trial NCT06618209: Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia
Official title: Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ciliary Dyskinesia
Caries,Dental
Quality of Life
Saliva Altered
Erosion, Dental Enamel
Keywords: primary ciliary dyskinesia
erosion, dental
oral health quality of life
dental caries
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Being followed up for a diagnosis of primary ciliary dyskinesia

Brief summary: The aim of this study is to compare the oral health findings, salivary parameters and pediatric oral health related quality of life of children with Primary Ciliary Dyskinesia (PCD) with healthy children

Detailed description: Primary Ciliary Dyskinesia (PCD) is a rare genetic disorder that affects the function of cilia, which are tiny hair-like structures responsible for moving mucus and other substances in the respiratory tract and other parts of the body. Dysfunctional cilia lead to impaired mucociliary clearance, resulting in chronic respiratory infections, sinusitis, and bronchiectasis. PCD can also cause situs inversus, where internal organs are mirrored from their normal positions, and other complications like chronic otitis media and fertility issues. Early diagnosis and management are crucial to prevent progressive lung damage and improve the quality of life in affected individuals.

This study aims to compare the oral and dental health of children diagnosed with Primary Ciliary Dyskinesia (PCD) to that of healthy controls. The study includes assessments of dental caries (using DMFT, dmft, and ICDAS II indices), salivary parameters (flow rate, pH, buffering capacity, oxidant-antioxidant levels, tissue factor activity), enamel defects (using the Modified Developmental Defects of Enamel Index), and oral hygiene (gingival and plaque indices). The Pediatric Oral Health-Related Quality of Life (POQL) scale will be used to evaluate the impact of oral health on quality of life.

Eligibility criteria: Inclusion Criteria:

* Not having any systemic disease.
* Not being on any regular medication.

Exclusion Criteria:

* Having any systemic disease.
* Being on any regular medication.

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: baseline
measure: Oral Health Status: DMFT/dft Index
timeFrame: baseline
measure: Oral Health Status: Gingival Index (GI)
timeFrame: baseline
measure: Oral Health Status: Developmental Defect of Enamel (DDE) Index
timeFrame: baseline
measure: Oral Health Status: Basic Erosive Wear Examination (BEWE)
timeFrame: baseline
measure: Oral Health Status: International Caries Detection and Assessment System (ICDAS-II)
timeFrame: baseline
measure: Salivary Analysis: Glutathione (GSH) and Lipid Peroxidation (LPO)
timeFrame: baseline
measure: Salivary Analysis: Total Antioxidant Status (TAS)
timeFrame: baseline
measure: Salivary Analysis: Total Oxidant Status (TOS)
timeFrame: baseline
measure: Salivary Analysis: Salivary Flow Rate
timeFrame: baseline
measure: Salivary Analysis: Superoxide Dismutase (SOD)
timeFrame: baseline
measure: Salivary Analysis: Oxidative Stress Index (OSI)
timeFrame: baseline
measure: Oral Health Status: Plaque Index (PI)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Dentistry
state: Maltepe
Study officials:
affiliation: Marmara University Faculty of Medicine
name: Bulent Karadag
role: STUDY_CHAIR
affiliation: Marmara University Faculty of Medicine
name: Ela Erdem Eralp
role: STUDY_CHAIR
affiliation: Marmara University Faculty of Medicine
name: Yasemin Gokdemir
role: STUDY_CHAIR
References: