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Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06618209
Enrollment
160
Registered
2024-10-01
Start date
2023-06-12
Completion date
2024-03-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

Salivary flow rate, pH

DIAGNOSTIC_TESTbiochemical methods

Total oxidant and antioxidant capacities, Lactoperoxidase, Oxidative Stress Index, Glutathione, Superoxide Dismutase

DIAGNOSTIC_TESTOral 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_TESTPediatric 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life (QoL)baselineThe Pediatric Oral Health Quality of Life (POQL) Scale is used to measure how oral heThe Pediatric Oral Health Quality of Life (POQL) Scale measures the impact of oral health on a child's quality of life. Scores range from 0 to 100, with higher scores indicating a worse outcome, reflecting a greater negative impact of oral health on daily life and well-being.alth impacts a child's daily activities, well-being, and overall quality of life.
Oral Health Status: DMFT/dft IndexbaselineDMFT/dft Index: Reported as numerical values representing the number of decayed (D), missing (M), and filled (F) teeth in the permanent (DMFT) and primary (dft) dentition. These values will reflect the overall dental health of participants by quantifying the extent of caries and treatment.
Oral Health Status: Gingival Index (GI)baselineGingival Index (GI): Reported as numerical values indicating the severity of gingival inflammation. GI scores range from 0 (healthy) to 3 (severe inflammation), giving insight into the participants' gum health.
Oral Health Status: Developmental Defect of Enamel (DDE) IndexbaselineDevelopmental Defect of Enamel (DDE) Index: Presented as the percentage of participants with observed enamel defects. This percentage helps quantify how many children experience developmental issues affecting enamel quality.
Oral Health Status: Basic Erosive Wear Examination (BEWE)baselineBasic Erosive Wear Examination (BEWE): Reported as the percentage of participants showing signs of erosive tooth wear. The BEWE score categorizes wear and provides a general picture of tooth surface loss due to erosion.
Oral Health Status: International Caries Detection and Assessment System (ICDAS-II)baselineInternational Caries Detection and Assessment System (ICDAS-II): Expressed as the percentage of participants with caries at various stages, from early demineralization to advanced decay. This system provides a nuanced view of the caries progression within the population.
Salivary Analysis: Glutathione (GSH) and Lipid Peroxidation (LPO)baselineGlutathione (GSH): Reported in µmol/L, measuring the concentration of this antioxidant. Lipid Peroxidation (LPO): Reported in µmol/L as malondialdehyde equivalents, indicating lipid peroxidation.
Salivary Analysis: Total Antioxidant Status (TAS)baselineTotal Antioxidant Status (TAS): Measured in µmol Trolox/L, indicating the saliva's antioxidant capacity.
Salivary Analysis: Total Oxidant Status (TOS)baselineTotal Oxidant Status (TOS): Expressed in µmol H₂O₂/L, reflecting oxidative stress in saliva.
Salivary Analysis: Salivary Flow RatebaselineSalivary Flow Rate: Measured in mL/min, representing the volume of saliva produced.
Salivary Analysis: Superoxide Dismutase (SOD)baselineSuperoxide Dismutase (SOD): Reported in U/mg protein, showing enzyme activity in neutralizing superoxide radicals.
Salivary Analysis: Oxidative Stress Index (OSI)baselineOxidative Stress Index (OSI): Calculated as the ratio of TOS to TAS, representing oxidative stress.
Oral Health Status: Plaque Index (PI)baselinePlaque Index (PI): Also reported as numerical values, representing the amount of plaque accumulation on the teeth. Like the GI, PI helps assess oral hygiene levels.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026