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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | physical and chemical methods | Salivary flow rate, pH |
| DIAGNOSTIC_TEST | biochemical methods | Total oxidant and antioxidant capacities, Lactoperoxidase, Oxidative Stress Index, Glutathione, Superoxide Dismutase |
| DIAGNOSTIC_TEST | Oral Findings | DMFT/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_TEST | Pediatric Oral Health Quality of Life | The 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.