Primary Ciliary DyskinesiaNCT06618209
Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia
An observational study of Primary Ciliary Dyskinesia and Caries,Dental, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Ciliary Dyskinesia, Caries,Dental, Quality of Life
- What is being tested?
- physical and chemical methods, biochemical methods and Oral Findings
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2023to 1 Mar 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Being followed up for a diagnosis of primary ciliary dyskinesia
Who may be able to join
- Not having any systemic disease.
- Not being on any regular medication.
Who cannot join
- Having any systemic disease.
- Being on any regular medication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Maltepe
About this study
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
Read the 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.
- Conditions
- Primary Ciliary Dyskinesia, Caries,Dental, Quality of Life, Saliva Altered, Erosion, Dental Enamel
- Being tested
- physical and chemical methods, biochemical methods, Oral Findings, Pediatric Oral Health Quality of Life
- Keywords
- primary ciliary dyskinesia, erosion, dental, oral health quality of life, dental caries
- Medical subject headings
- Ciliary Motility Disorders, Dental Caries, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical and chemical methodsDiagnostic test
Salivary flow rate, pH
biochemical methodsDiagnostic test
Total oxidant and antioxidant capacities, Lactoperoxidase, Oxidative Stress Index, Glutathione, Superoxide Dismutase
Oral FindingsDiagnostic 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 LifeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Diagnostic Test: Pediatric Oral Health Quality of Life | |
| Parents of healthy children group | Parents of children aged 6-17 healthy children Receives: Diagnostic Test: Pediatric Oral Health Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Salivary Analysis: Total Antioxidant Status (TAS)
Total Antioxidant Status (TAS): Measured in µmol Trolox/L, indicating the saliva's antioxidant capacity.
Measured: baseline
Salivary Analysis: Total Oxidant Status (TOS)
Total Oxidant Status (TOS): Expressed in µmol H₂O₂/L, reflecting oxidative stress in saliva.
Measured: baseline
Salivary Analysis: Salivary Flow Rate
Salivary Flow Rate: Measured in mL/min, representing the volume of saliva produced.
Measured: baseline
Salivary Analysis: Superoxide Dismutase (SOD)
Superoxide Dismutase (SOD): Reported in U/mg protein, showing enzyme activity in neutralizing superoxide radicals.
Measured: baseline
Salivary Analysis: Oxidative Stress Index (OSI)
Oxidative Stress Index (OSI): Calculated as the ratio of TOS to TAS, representing oxidative stress.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start12 Jun 2023
- Primary completion20 Aug 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bulent Karadag, Study chair, Marmara University Faculty of MedicineEla Erdem Eralp, Study chair, Marmara University Faculty of MedicineYasemin Gokdemir, Study chair, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618209
- Sponsor's protocol ID
- 09.2023.305
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41221835
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Health Status of Children With Primary Ciliary Dyskinesia
- ClinicalTrials.gov ID
- NCT06618209
- Acronym / sponsor ID
- 09.2023.305
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with primary ciliary dyskinesia group | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: Oral Findings, Diagnostic Test: Pediatric Oral Health Quality of LifeIt is a group of patients between the ages of 6 and 17 who have recently been diagnosed with primary ciliary dyskinesia |
| healthy patient group | – | Diagnostic Test: physical and chemical methods, Diagnostic Test: biochemical methods, Diagnostic Test: Oral Findings, Diagnostic Test: Pediatric Oral Health Quality of LifeHealthy 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 | – | Diagnostic Test: Pediatric Oral Health Quality of LifeParents of children aged 6-17 with Primary Ciliary Dyskinesia |
| Parents of healthy children group | – | Diagnostic Test: Pediatric Oral Health Quality of LifeParents of children aged 6-17 healthy children |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Being followed up for a diagnosis of primary ciliary dyskinesia
Key inclusion criteria (2 listed)
- Not having any systemic disease.
- Not being on any regular medication.
Key exclusion criteria (2 listed)
- Having any systemic disease.
- Being on any regular medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical and chemical methodsSalivary flow rate, pH | Diagnostic test | Children with primary ciliary dyskinesia group, healthy patient group |
| biochemical methodsTotal oxidant and antioxidant capacities, Lactoperoxidase, Oxidative Stress Index, Glutathione, Superoxide Dismutase | Diagnostic test | Children with primary ciliary dyskinesia group, healthy patient group |
| Oral FindingsDMFT/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 | Children with primary ciliary dyskinesia group, healthy patient group |
| Pediatric Oral Health Quality of LifeThe 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. | Diagnostic test | Children with primary ciliary dyskinesia group, Parents of children with Primary Ciliary Dyskinesia group, Parents of healthy children group, healthy patient group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Salivary Analysis: Total Antioxidant Status (TAS)
Time frame: baseline
Total Antioxidant Status (TAS): Measured in µmol Trolox/L, indicating the saliva's antioxidant capacity.
Salivary Analysis: Total Oxidant Status (TOS)
Time frame: baseline
Total Oxidant Status (TOS): Expressed in µmol H₂O₂/L, reflecting oxidative stress in saliva.
Salivary Analysis: Salivary Flow Rate
Time frame: baseline
Salivary Flow Rate: Measured in mL/min, representing the volume of saliva produced.
Salivary Analysis: Superoxide Dismutase (SOD)
Time frame: baseline
Superoxide Dismutase (SOD): Reported in U/mg protein, showing enzyme activity in neutralizing superoxide radicals.
Salivary Analysis: Oxidative Stress Index (OSI)
Time frame: baseline
Oxidative Stress Index (OSI): Calculated as the ratio of TOS to TAS, representing oxidative stress.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 41221835Oztuna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Karadag study chair
Marmara University Faculty of Medicine
Ela Erdem Eralp study chair
Marmara University Faculty of Medicine
Yasemin Gokdemir study chair
Marmara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ciliary Dyskinesia and Caries,Dental, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.