Periodontal DiseasesNCT03910205
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
An observational study of Periodontal Diseases, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- ELISA
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 30 Jun 2019
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 88 Children with diabetes mellitus and systemically healty children with and without gingivitis.
Who may be able to join
- Children diagnosed as type 1 diabetes mellitus
- Age between 7 and 14 years
Who cannot join
- Having another systemic problem except type 1 diabetes mellitus
- Children carrying orthodontic appliances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.
Read the detailed description
Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.
- Conditions
- Periodontal Diseases
- Being tested
- ELISA
- Keywords
- interleukin-18, gingival crevicular fluid, tumor necrosis factor alpha
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Enzim linked immunoabsorbant assay
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes with gingivitis | Children with type 1 diabetes mellitus and gingivitis Receives: Diagnostic Test: ELISA | |
| Type 1 diabetes with healthy gingiva | Children with type 1 diabetes mellitus and healthy gingiva Receives: Diagnostic Test: ELISA | |
| Healthy patients with gingivitis | Systemically healthy patients with gingivitis Receives: Diagnostic Test: ELISA | |
| Healthy patients with healthy gingiva | Systemically healthy patients with healthy gingiva Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-18 level
IL-18
Measured: Baseline
Secondary outcomes (1)
Tnf-alpha level
Tnf-Alpha
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start8 Apr 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
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
- Investigators
- Sultan KELES, Dr., Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910205
- Sponsor's protocol ID
- 2019-062
- Status last verified
- Jul 2019
- First submitted
- 9 Apr 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03910205
- Acronym / sponsor ID
- 2019-062
- Conditions
- Periodontal Diseases
- Keywords
- interleukin-18, gingival crevicular fluid, tumor necrosis factor alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Apr 2019 (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 aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.
Detailed description
Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes with gingivitis | – | Diagnostic Test: ELISAChildren with type 1 diabetes mellitus and gingivitis |
| Type 1 diabetes with healthy gingiva | – | Diagnostic Test: ELISAChildren with type 1 diabetes mellitus and healthy gingiva |
| Healthy patients with gingivitis | – | Diagnostic Test: ELISASystemically healthy patients with gingivitis |
| Healthy patients with healthy gingiva | – | Diagnostic Test: ELISASystemically healthy patients with healthy gingiva |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 88 Children with diabetes mellitus and systemically healty children with and without gingivitis.
Key inclusion criteria (2 listed)
- Children diagnosed as type 1 diabetes mellitus
- Age between 7 and 14 years
Key exclusion criteria (2 listed)
- Having another systemic problem except type 1 diabetes mellitus
- Children carrying orthodontic appliances
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 |
|---|---|---|
| ELISAEnzim linked immunoabsorbant assay | Diagnostic test | Healthy patients with gingivitis, Healthy patients with healthy gingiva, Type 1 diabetes with gingivitis, Type 1 diabetes with healthy gingiva |
Primary outcome
Interleukin-18 level
Time frame: Baseline
IL-18
1 secondary outcome
Tnf-alpha level
Time frame: Baseline
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 29 Nov 2019.
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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.
Sultan KELES, Dr. principal investigator
Dr.
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 Periodontal Diseases, 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 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 29 Nov 2019. 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?
Interleukin-18 level (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 29 Nov 2019.