Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

NCT06618209 | Completed

• 1 other identifier: 09.2023.305
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (13)

• Quality of Life (QoL)

  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.

  baseline

• Oral Health Status: DMFT/dft Index

  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.

  baseline

• Oral Health Status: Gingival Index (GI)

  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.

  baseline

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

  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.

  baseline

• Oral Health Status: Basic Erosive Wear Examination (BEWE)

  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.

  baseline

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

  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.

  baseline

• Salivary Analysis: Glutathione (GSH) and Lipid Peroxidation (LPO)

  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.

  baseline

• Salivary Analysis: Total Antioxidant Status (TAS)

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

  baseline

• Salivary Analysis: Total Oxidant Status (TOS)

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

  baseline

• Salivary Analysis: Salivary Flow Rate

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

  baseline

• Salivary Analysis: Superoxide Dismutase (SOD)

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

  baseline

• Salivary Analysis: Oxidative Stress Index (OSI)

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

  baseline

• Oral Health Status: Plaque Index (PI)

  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.

  baseline

Study Arms (4)

Children with primary ciliary dyskinesia group

It is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia

Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: Oral Findings; Diagnostic Test: Pediatric Oral Health Quality of Life

healthy patient group

Healthy children aged between 6 and 17 years, with no systemic diseases and not taking any regular medications.

Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: Oral Findings; Diagnostic Test: Pediatric Oral Health Quality of Life

Parents of children with Primary Ciliary Dyskinesia group

Parents of children aged 6-17 with Primary Ciliary Dyskinesia

Diagnostic Test: Pediatric Oral Health Quality of Life

Parents of healthy children group

Parents of children aged 6-17 healthy children

Diagnostic Test: Pediatric Oral Health Quality of Life

Interventions

physical and chemical methods DIAGNOSTIC_TEST

Salivary flow rate, pH

Children with primary ciliary dyskinesia group; healthy patient group

biochemical methods DIAGNOSTIC_TEST

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

Children with primary ciliary dyskinesia group; healthy patient group

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

Children with primary ciliary dyskinesia group; healthy patient group

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.

Children with primary ciliary dyskinesia group; Parents of children with Primary Ciliary Dyskinesia group; Parents of healthy children group; healthy patient group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Being followed up for a diagnosis of primary ciliary dyskinesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Maltepe, Turkey (Türkiye)

Location

Related Publications (1)

• Oztuna EK, Peker S, Eralp EE, Gokdemir Y, Karadag B. Oral Health Status and Oral Health-Related Quality of Life in Children With Primary Ciliary Dyskinesia. Pediatr Pulmonol. 2025 Nov;60(11):e71370. doi: 10.1002/ppul.71370.

  PMID: 41221835 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Ciliary Motility Disorders; Dental Caries; Tooth Erosion

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bulent Karadag

  Marmara University Faculty of Medicine

  STUDY CHAIR

• Ela Erdem Eralp

  Marmara University Faculty of Medicine

  STUDY CHAIR

• Yasemin Gokdemir

  Marmara University Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 1, 2024
• Study Start: June 12, 2023
• Primary Completion: August 20, 2023
• Study Completion: March 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TU (1)