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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Primary Ciliary Dyskinesia; Caries,Dental; Saliva Altered; Erosion, Dental Enamel
• Intervention / Treatment: Diagnostic test: physical and chemical methods; Diagnostic test: biochemical methods; Diagnostic test: Oral Findings; Diagnostic test: Pediatric Oral Health Quality of Life

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey
      • Marmara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Being followed up for a diagnosis of primary ciliary dyskinesia

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.
Parents of healthy children group; Parents of children aged 6-17 healthy children	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: dental caries; primary ciliary dyskinesia; erosion, dental; oral health quality of life
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Movement Disorders; Tooth Demineralization; Tooth Diseases; Abnormalities, Multiple; Ciliopathies; Dental Caries; Dyskinesias; Ciliary Motility Disorders
• Other Study ID Numbers: 09.2023.305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No