Periodontal DiseasesNCT04470635
Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children
An observational study of Periodontal Diseases, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- ELISA
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2020to 1 Oct 2020
- 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
- Child
Study population: Eigthy children will be recuited for the study . The children will be classified into four subgroups based on their periodontal status; 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis (G), 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis . The plaque index, gingival index and probing pocket depth will be recorded. The vascular endothelial growth factor in saliva will be determined by ELISA. Additionally total and native thiao and disulphide levels in saliva will be determined.
Who may be able to join
- Children diagnosed as type 1 diabetes mellitus
- Age between 7-14 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: Thiol/Disulphide Homeostasis and Salivary Vascular Endothelial Growth Factor Levels in Type 1 Diabetic Patients With Gingivitis
The aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.
Read the detailed description
Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. The children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket depth, will recorded. The vascular endothelial growth factor level determined by ELISA. Native thiol, total thiol and disulphide levels will be measured in saliva.
- Conditions
- Periodontal Diseases
- Being tested
- ELISA
- Keywords
- type 1 diabetes mellitus
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Also called Thiol/disulphide measurement, Total thiol, native thiol and disulphide level
Saliva sample collection
| 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 children with gingivitis | Systemically healthy children with gingivitis Receives: Diagnostic Test: ELISA | |
| Healthy children and healthy gingiva | Systemically healthy children with healthy gingiva Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular endothelial growth factor level
Vascular endothelial growth factor level in saliva
Measured: Baseline
Secondary outcomes (1)
Thiol/disulphide measurement
Total thiol, native thiol and disulphite level in saliva
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start25 Jul 2020
- Primary completion30 Sep 2020
- Study completion1 Oct 2020
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
- 80 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, Assoc.Prof., Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470635
- Sponsor's protocol ID
- 2020/114
- Status last verified
- Jan 2024
- First submitted
- 10 Jul 2020
- Last updated
- 30 Jan 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiol/Disulphide Homeostasis and Salivary Vascular Endothelial Growth Factor Levels in Type 1 Diabetic Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT04470635
- Acronym / sponsor ID
- 2020/114
- Conditions
- Periodontal Diseases
- Keywords
- type 1 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 14 Jul 2020 (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 to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.
Detailed description
Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. The children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket depth, will recorded. The vascular endothelial growth factor level determined by ELISA. Native thiol, total thiol and disulphide levels will be measured in saliva.
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 children with gingivitis | – | Diagnostic Test: ELISASystemically healthy children with gingivitis |
| Healthy children and healthy gingiva | – | Diagnostic Test: ELISASystemically healthy children with healthy gingiva |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Eigthy children will be recuited for the study . The children will be classified into four subgroups based on their periodontal status; 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis (G), 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis . The plaque index, gingival index and probing pocket depth will be recorded. The vascular endothelial growth factor in saliva will be determined by ELISA. Additionally total and native thiao and disulphide levels in saliva will be determined.
Key inclusion criteria (2 listed)
- Children diagnosed as type 1 diabetes mellitus
- Age between 7-14 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 |
|---|---|---|
| ELISAAlso: Thiol/disulphide measurement, Total thiol, native thiol and disulphide levelSaliva sample collection | Diagnostic test | Healthy children and healthy gingiva, Healthy children with gingivitis, Type 1 diabetes with gingivitis, Type 1 diabetes with healthy gingiva |
Primary outcome
Vascular endothelial growth factor level
Time frame: Baseline
Vascular endothelial growth factor level in saliva
1 secondary outcome
Thiol/disulphide measurement
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 30 Jan 2024.
- Individual participant dataSharing planned: No
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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, Assoc.Prof. principal investigator
Aydin Adnan Menderes University
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 30 Jan 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?
Vascular endothelial growth factor 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 30 Jan 2024.