Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia

Completed

• Conditions: Primary Ciliary Dyskinesia; Caries,Dental; Quality of Life; Saliva Altered; Erosion, Dental Enamel
• Interventions: Diagnostic Test: physical and chemical methods; Diagnostic Test: biochemical methods; Diagnostic Test: Oral Findings; Diagnostic Test: Pediatric Oral Health Quality of Life

• Registration Number: NCT06618209
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2023-06-12
• Primary Completion: 2023-08-20
• Study Completion: 2024-03-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with primary ciliary dyskinesia group	physical and chemical methods	It is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia
Children with primary ciliary dyskinesia group	biochemical methods	It is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia
Children with primary ciliary dyskinesia group	Oral Findings	It is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia
Children with primary ciliary dyskinesia group	Pediatric Oral Health Quality of Life	It is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia
healthy patient group	physical and chemical methods	Healthy children aged between 6 and 17 years, with no systemic diseases and not taking any regular medications.
healthy patient group	biochemical methods	Healthy children aged between 6 and 17 years, with no systemic diseases and not taking any regular medications.
healthy patient group	Oral Findings	Healthy children aged between 6 and 17 years, with no systemic diseases and not taking any regular medications.
healthy patient group	Pediatric Oral Health Quality of Life	Healthy children aged between 6 and 17 years, with no systemic diseases and not taking any regular medications.
Parents of children with Primary Ciliary Dyskinesia group	Pediatric Oral Health Quality of Life	Parents of children aged 6-17 with Primary Ciliary Dyskinesia
Parents of healthy children group	Pediatric Oral Health Quality of Life	Parents of children aged 6-17 healthy children

Primary Outcome Measures

Name	Time	Method
Oral Health Status: Gingival Index (GI)	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.
Quality of Life (QoL)	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.
Oral Health Status: DMFT/dft Index	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.
Oral Health Status: Developmental Defect of Enamel (DDE) Index	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.
Oral Health Status: Basic Erosive Wear Examination (BEWE)	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.
Oral Health Status: International Caries Detection and Assessment System (ICDAS-II)	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.
Salivary Analysis: Glutathione (GSH) and Lipid Peroxidation (LPO)	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.
Salivary Analysis: Total Antioxidant Status (TAS)	baseline	Total Antioxidant Status (TAS): Measured in µmol Trolox/L, indicating the saliva's antioxidant capacity.
Salivary Analysis: Total Oxidant Status (TOS)	baseline	Total Oxidant Status (TOS): Expressed in µmol H₂O₂/L, reflecting oxidative stress in saliva.
Salivary Analysis: Salivary Flow Rate	baseline	Salivary Flow Rate: Measured in mL/min, representing the volume of saliva produced.
Salivary Analysis: Superoxide Dismutase (SOD)	baseline	Superoxide Dismutase (SOD): Reported in U/mg protein, showing enzyme activity in neutralizing superoxide radicals.
Salivary Analysis: Oxidative Stress Index (OSI)	baseline	Oxidative Stress Index (OSI): Calculated as the ratio of TOS to TAS, representing oxidative stress.
Oral Health Status: Plaque Index (PI)	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.

Trial Locations

Locations (1)

Marmara University Faculty of Dentistry; 🇹🇷 Istanbul, Maltepe, Turkey