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Trials / Completed

CompletedNCT06618209

Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

Status
Completed
Phase
Study type
Observational
Enrollment
160 (actual)
Sponsor
Marmara University · Academic / Other
Sex
All
Age
6 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTphysical and chemical methodsSalivary flow rate, pH
DIAGNOSTIC_TESTbiochemical methodsTotal oxidant and antioxidant capacities, Lactoperoxidase, Oxidative Stress Index, Glutathione, Superoxide Dismutase
DIAGNOSTIC_TESTOral FindingsDMFT/dft Index: Measures decayed, missing, and filled teeth. ICDAS II: International Caries Detection and Assessment System, used for detecting and assessing dental caries. DDE Index: Developmental Defects of Enamel index.GI (Gingival Index): Assesses the severity of gingivitis based on inflammation.PI (Plaque Index): Assesses the severity of plaque based on inflammation. basic erosive wear examination: measures dental erosion
DIAGNOSTIC_TESTPediatric Oral Health Quality of LifeThe Pediatric Oral Health Quality of Life (POQL) Scale is a tool used to assess the impact of oral health conditions on the overall quality of life in children.

Timeline

Start date
2023-06-12
Primary completion
2023-08-20
Completion
2024-03-01
First posted
2024-10-01
Last updated
2024-10-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06618209. Inclusion in this directory is not an endorsement.