PeriodontitisNCT06540755
Analysis of Pregnancy-Associated Plasma Protein-A and Interleukin-6 Gene Polymorphisms in Patients With Periodontitis
An observational study of Periodontitis and Polymorphism, Restriction Fragment Length, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the relationship between pregnancy associated plasma protein-A (PAPP-A) and interleukin-6 (IL-6) gene polymorphisms and stage 3 grade B and C (S3GBC) periodontitis, and to compare periodontitis patients with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Polymorphism, Restriction Fragment Length
- What is being tested?
- genetic polymorphism analysis
- How many people
- 226 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2022to 28 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group H: The periodontally healthy individuals had an absence of detectable bone and attachment loss, less than 10% of sites with bleeding on probing, and probing depths of ≤3 mm. Group P: Stage III grade B or grade C periodontitis patients were diagnosed on the base of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
Who may be able to join
- Participants were eligible for inclusion if they were; systemically healthy non-smokers had not undergone periodontal treatment in the past 6 months had not used antibiotics or anti-inflammatory drugs in the preceding 3 months had not used any medication that could affect periodontal tissues in the past 6 months were 18 years of age or older were not pregnant, and were not lactating.
Who cannot join
- The samples taken cannot be stored under appropriate conditions and are damaged.
- The onset of a systemic disease in a systemically healthy individual.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Dental Faculty Periodontology Departmen
Istanbul
About this study
The aim of this study is to evaluate the relationship between pregnancy associated plasma protein-A (PAPP-A) and interleukin-6 (IL-6) gene polymorphisms and stage 3 grade B and C (S3GBC) periodontitis, and to compare periodontitis patients with healthy individuals.
Read the detailed description
A total of 226 systemically healthy subjects, consisted of 112 S3GBC periodontitis patients (P group) and 114 periodontally healthy individuals (H group) were included in our study. Clinical and demographic data were recorded. Genomic deoxyribonucleic acid (DNA) molecules were obtained from peripheral blood. Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes. The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms were similar between groups (p>0.05). Our finding suggests that there is no relationship between PAPP-A and IL-6 gene polymorphismS and S3GBC periodontitis, furthermore no difference was detected between periodontitis patients and healthy individuals regarding this gene polymorphism.
- Being tested
- genetic polymorphism analysis
- Keywords
- Polymorphism, Pregnancy-Associated Plasma Protein-A, Interleukin-6, genetic
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic polymorphism analysisGenetic
Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes.
| Study group | Role | What they receive |
|---|---|---|
| H Group | periodontally healthy individuals Receives: Genetic: genetic polymorphism analysis | |
| P Group | stage 3 grade B and C periodontitis patients Receives: Genetic: genetic polymorphism analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms
they were similar between groups
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start2 Dec 2022
- Primary completion26 Jan 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540755
- Sponsor's protocol ID
- 09.2022.1611
- Other IDs
- TDH-2023-10969
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Pregnancy-Associated Plasma Protein-A and Interleukin-6 Gene Polymorphisms in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT06540755
- Acronym / sponsor ID
- 09.2022.1611
- Keywords
- Polymorphism, Pregnancy-Associated Plasma Protein-A, Interleukin-6, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 6 Aug 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 evaluate the relationship between pregnancy associated plasma protein-A (PAPP-A) and interleukin-6 (IL-6) gene polymorphisms and stage 3 grade B and C (S3GBC) periodontitis, and to compare periodontitis patients with healthy individuals.
Detailed description
A total of 226 systemically healthy subjects, consisted of 112 S3GBC periodontitis patients (P group) and 114 periodontally healthy individuals (H group) were included in our study. Clinical and demographic data were recorded. Genomic deoxyribonucleic acid (DNA) molecules were obtained from peripheral blood. Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes. The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms were similar between groups (p>0.05). Our finding suggests that there is no relationship between PAPP-A and IL-6 gene polymorphismS and S3GBC periodontitis, furthermore no difference was detected between periodontitis patients and healthy individuals regarding this gene polymorphism.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H Group | – | Genetic: genetic polymorphism analysisperiodontally healthy individuals |
| P Group | – | Genetic: genetic polymorphism analysisstage 3 grade B and C periodontitis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group H: The periodontally healthy individuals had an absence of detectable bone and attachment loss, less than 10% of sites with bleeding on probing, and probing depths of ≤3 mm. Group P: Stage III grade B or grade C periodontitis patients were diagnosed on the base of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
Key inclusion criteria (1 listed)
- Participants were eligible for inclusion if they were; systemically healthy non-smokers had not undergone periodontal treatment in the past 6 months had not used antibiotics or anti-inflammatory drugs in the preceding 3 months had not used any medication that could affect periodontal tissues in the past 6 months were 18 years of age or older were not pregnant, and were not lactating.
Key exclusion criteria (2 listed)
- The samples taken cannot be stored under appropriate conditions and are damaged.
- The onset of a systemic disease in a systemically healthy individual.
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 |
|---|---|---|
| genetic polymorphism analysisGenotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes. | Genetic | H Group, P Group |
Primary outcome
The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms
Time frame: baseline
they were similar between groups
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 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis and Polymorphism, Restriction Fragment Length, 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 1 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 6 Aug 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?
The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.