GingivitisNCT06507280
The Effects of Periodontal Therapy on Gingival Crevicular Fluid NLRP3,Caspase-1,IL-1β Levels in Children With Gingivitis
A study testing Periodontal theraphy in people with Gingivitis, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the levels of NLRP3, caspase-1 and IL-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Periodontal theraphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Jan 2025
- Phase
- Interventional
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically healthy
- 11-14 years old
- Permanent dentition
- No need for endodontic and restorative treatment
- Gingivitis with gingivitis
- Have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study.
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- Systemically healthy
- 11-14 years old
- Permanent dentition
- No need for endodontic and restorative treatment
- Periodontally healthy
- Have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study.
Who cannot join
- In need of endodontic and restorative treatment
- Systemically unhealthy
- Patients who do not give verbal or written consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Keles
Aydin, 09100
Sultan Keles, Assoc.Prof.dr, 05318438557, dtsultank@gmail.com
Nazlı Sevilmiş
About this study
This study aims to determine the levels of NLRP3, caspase-1 and IL-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment.
Read the detailed description
After being informed about the study and potential risks, necessary periodontal measurements will be performed and gingival crevicular fluid will be collected from all patients who gave written informed consent, and patients with gingivitis will be followed up on the 7th and 30th day after periodontal treatment.
- Conditions
- Gingivitis
- Being tested
- Periodontal theraphy
- Keywords
- NLRP3, CASPASE-1, IL-1β, GINGIVITIS, GCF
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal theraphyProcedure or surgery
periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis Group | Experimental | In the first session, gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made, plaques on the teeth will be cleaned and oral hygiene training will be performed. On the 7th and 30th days, gingival crevicular fluid will be taken again and periodontal measurements will be made. Receives: Procedure: Periodontal theraphy |
| Healthy Group | No intervention | Gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
NLRP3
NOD-, LRR- and pyrin domain-containing protein 3 level
Measured: Baseline
Caspase-1
Caspase-1 level
Measured: Baseline
IL-1 Beta
Interleukin-1 Beta level
Measured: Baseline
Secondary outcomes (3)
NLRP3
NOD-, LRR- and pyrin domain-containing protein 3 level
Measured: 7. days - 30. days
Caspase-1
Caspase-1 level
Measured: 7. days -30. days
IL-1 Beta
Interleukin-1 Beta level
Measured: 7. days-30. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Feb 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507280
- Sponsor's protocol ID
- 2024/43
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Periodontal Therapy on Gingival Crevicular Fluid NLRP3,Caspase-1,IL-1β Levels in Children With Gingivitis
- ClinicalTrials.gov ID
- NCT06507280
- Acronym / sponsor ID
- 2024/43
- Conditions
- Gingivitis
- Keywords
- NLRP3, CASPASE-1, IL-1β, GINGIVITIS, GCF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Jul 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.
This study aims to determine the levels of NLRP3, caspase-1 and IL-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment.
Detailed description
After being informed about the study and potential risks, necessary periodontal measurements will be performed and gingival crevicular fluid will be collected from all patients who gave written informed consent, and patients with gingivitis will be followed up on the 7th and 30th day after periodontal treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingivitis Group | Experimental | Procedure: Periodontal theraphyIn the first session, gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made, plaques on the teeth will be cleaned and oral hygiene training will be performed. On the 7th and 30th days, gingival crevicular fluid will be taken again and periodontal measurements will be made. |
| Healthy Group | No intervention | –Gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Systemically healthy
- 11-14 years old
- Permanent dentition
- No need for endodontic and restorative treatment
- Gingivitis with gingivitis
Key exclusion criteria (3 listed)
- In need of endodontic and restorative treatment
- Systemically unhealthy
- Patients who do not give verbal or written consent
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 |
|---|---|---|
| Periodontal theraphyperiodontal therapy | Procedure or surgery | Gingivitis Group |
Primary outcome
NLRP3
Time frame: Baseline
NOD-, LRR- and pyrin domain-containing protein 3 level
Caspase-1
Time frame: Baseline
Caspase-1 level
IL-1 Beta
Time frame: Baseline
Interleukin-1 Beta level
3 secondary outcomes
NLRP3
Time frame: 7. days - 30. days
Caspase-1
Time frame: 7. days -30. days
IL-1 Beta
Time frame: 7. days-30. days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Not yet recruitingPhase 2
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal theraphy in people with Gingivitis, run by Aydin Adnan Menderes 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 12 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sultan Keleş, Assoc.Prof. (05318438557 ext. +90, dtsultank@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NLRP3 (time frame: Baseline). The study lists 3 primary outcomes in all. 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 18 Jul 2024.