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Completed

NCT Number: NCT06618209

Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

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

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Key information

Conditions

Primary Ciliary Dyskinesia Abnormalities, Multiple Caries,Dental Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Caries Erosion, Dental Enamel Genetic Diseases, Inborn Otorhinolaryngologic Diseases Quality of Life Respiratory Tract Diseases Saliva Altered Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Faculty of Dentistry

Istanbul, Maltepe, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

physical and chemical methods

Diagnostic Test

Salivary flow rate, pH

biochemical methods

Diagnostic Test

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

Oral Findings

Diagnostic Test

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

Pediatric Oral Health Quality of Life

Diagnostic Test

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.

Primary outcomes

  1. Quality of Life (QoL)

    Time frame: baseline

    The 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.

  2. Oral Health Status: DMFT/dft Index

    Time frame: baseline

    DMFT/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.

  3. Oral Health Status: Gingival Index (GI)

    Time frame: baseline

    Gingival 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.

  4. Oral Health Status: Developmental Defect of Enamel (DDE) Index

    Time frame: baseline

    Developmental 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.

  5. Oral Health Status: Basic Erosive Wear Examination (BEWE)

    Time frame: baseline

    Basic 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.

  6. Oral Health Status: International Caries Detection and Assessment System (ICDAS-II)

    Time frame: baseline

    International 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.

  7. Salivary Analysis: Glutathione (GSH) and Lipid Peroxidation (LPO)

    Time frame: baseline

    Glutathione (GSH): Reported in µmol/L, measuring the concentration of this antioxidant. Lipid Peroxidation (LPO): Reported in µmol/L as malondialdehyde equivalents, indicating lipid peroxidation.

  8. Salivary Analysis: Total Antioxidant Status (TAS)

    Time frame: baseline

    Total Antioxidant Status (TAS): Measured in µmol Trolox/L, indicating the saliva's antioxidant capacity.

  9. Salivary Analysis: Total Oxidant Status (TOS)

    Time frame: baseline

    Total Oxidant Status (TOS): Expressed in µmol H₂O₂/L, reflecting oxidative stress in saliva.

  10. Salivary Analysis: Salivary Flow Rate

    Time frame: baseline

    Salivary Flow Rate: Measured in mL/min, representing the volume of saliva produced.

  11. Salivary Analysis: Superoxide Dismutase (SOD)

    Time frame: baseline

    Superoxide Dismutase (SOD): Reported in U/mg protein, showing enzyme activity in neutralizing superoxide radicals.

  12. Salivary Analysis: Oxidative Stress Index (OSI)

    Time frame: baseline

    Oxidative Stress Index (OSI): Calculated as the ratio of TOS to TAS, representing oxidative stress.

  13. Oral Health Status: Plaque Index (PI)

    Time frame: baseline

    Plaque 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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