Periodontal DiseasesNCT06306937
Serum Levels of Vitamin D and IL8 in Patients With Periodontitis
An observational study of Periodontal Diseases, run by Mansoura University at 1 site in Egypt.
Trial summary
We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Evalution of serum levels of vitamin D and IL8
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Sep 2023
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Periodontitis Group: Individuals diagnosed with periodontitis, meet specific criteria such as a minimum of 40% of sites with CAL ≥2 mm, PD ≥4 mm, and ≥40% of sites with bleeding on probing. This group represented individuals with varying degrees of periodontal disease. Control Group: Healthy individuals, age, and gender-matched, devoid of systemic diseases, and medications, and with no sites exhibiting PD ≥4 mm or CAL ≥4 mm. This group provided a baseline for periodontal health in the absence of diagnosed periodontitis. The study's observational design allowed for the comprehensive examination of these groups, shedding light on the interplay between serum biomarkers, vitamin D, IL8, and periodontal health in a real-world setting. Population diversity enhances the generalizability of findings beyond specific clinical or demographic subsets.
Who may be able to join
- presence of at least twenty teeth.
- Periodontitis patients with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2 mm and probing depth (PD)≥4 mm.
- presence of ≥40% sites with bleeding on probing.
- Healthy individuals matched for age and gender, who presented no systemic disease, no drugs were taken, no sites with PD ≥4 mm or CAL ≥4 mm, or radiographic signs of bone loss were enrolled, such as a control group.
Who cannot join
- Intake of contraceptives, immunosuppressive, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study.
- Pregnant and lactating females.
- Diabetic patients.
- History of medications that might affect bone and mineral metabolism and/or periodontal health.
- Taking multivitamins and food supplement which contain vitamin D.
- Malabsorption syndrome or patient with chronic diarrhea.
- Treatment with bisphosphonates in the past 12 months or lifetime exposure to bisphosphonates for more than 3 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University, Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Serum Levels of Vitamin D and IL8 in Patients With Periodontitis: A Case-control Study
We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis.
Read the detailed description
The primary objective of this study is to assess the levels of vitamin D and IL8 in the serum of individuals diagnosed with periodontitis and compare them with those of a healthy control group. The study also aims to establish correlations between these serum levels and the degree of periodontitis severity.
Two groups will be recruited: patients diagnosed with periodontitis and a control group consisting of individuals without periodontal disease.
The participants will be matched for age, gender, and other relevant demographic factors to minimize confounding variables.
Serum samples will be collected from both groups. Periodontitis severity will be determined using established clinical indices, such as probing depth, clinical attachment loss, and bleeding on probing.
Vitamin D levels in the serum will be measured using standardized laboratory techniques.
IL8 levels in the serum will also be quantified using appropriate assays. Statistical analyses will be performed to identify any significant correlations between vitamin D levels, IL8 levels, and the severity of periodontitis.
Subgroup analyses may be conducted to explore potential variations based on demographic factors or other relevant variables.
The study will adhere to ethical guidelines, ensuring participant confidentiality, informed consent, and responsible data handling.
The study anticipates finding associations or correlations between serum levels of vitamin D and IL8 and the severity of periodontitis. This information may contribute to a better understanding of the role of these factors in periodontal health and could have implications for future preventive and therapeutic strategies.
- Conditions
- Periodontal Diseases
- Being tested
- Evalution of serum levels of vitamin D and IL8
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evalution of serum levels of vitamin D and IL8Diagnostic test
Group 1 (Periodontitis Group): The intervention involves observing and analyzing individuals diagnosed with periodontitis based on established clinical criteria. The focus is on assessing vitamin D and IL8 levels in the serum and correlating these levels with the severity of periodontitis, determined by clinical indices such as probing depth, clinical attachment loss, and bleeding on probing.
Group 2 (Control Group): The intervention involves observing and analyzing individuals without any signs or history of periodontal disease. The focus is on assessing vitamin D and IL8 levels in the serum for comparison with the periodontitis group. This group serves as the healthy control for the study.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Individuals diagnosed with periodontitis based on established clinical criteria. This group will include participants who exhibit signs and symptoms of periodontal disease, such as probing depth, clinical attachment loss, and bleeding on probing. Receives: Diagnostic Test: Evalution of serum levels of vitamin D and IL8 | |
| Control | Individuals without any signs or history of periodontal disease. This group will consist of participants who do not have clinically diagnosed periodontitis and serve as the healthy control group for comparison with the periodontitis group. Receives: Diagnostic Test: Evalution of serum levels of vitamin D and IL8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Levels of 25(OH)vitamin D
Measurement of vitamin D levels (categorized as deficient, inadequate, or adequate) using a commercial ELISA kit.
Measured: Laboratory evaluation after samples collection. it was performed in 1 month
Serum Levels of IL8
Measurement of IL8 levels (expressed in pg/ml) using a commercial ELISA kit.
Measured: Laboratory evaluation after samples collection. it was performed in 1 month
Secondary outcomes (3)
Plaque Index (Pl)
Assessment of dental plaque presence and severity on a scale of 0 to 3.
Measured: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Clinical Attachment Loss (CAL)
Measurement in millimeters from CEJ to the most apically probable portion.
Measured: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Probing Pocket Depth (PPD)
Measurement in millimeters from the gingival margin to the most apically probable portion.
Measured: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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 Mansoura 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Saleh, Mansoura University
- Investigators
- Wafaa saleh, Ph.D, Principal investigator, Mansoura University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306937
- Sponsor's protocol ID
- A24020822
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Vitamin D and IL8 in Patients With Periodontitis: A Case-control Study
- ClinicalTrials.gov ID
- NCT06306937
- Acronym / sponsor ID
- A24020822
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Mar 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.
We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis.
Detailed description
The primary objective of this study is to assess the levels of vitamin D and IL8 in the serum of individuals diagnosed with periodontitis and compare them with those of a healthy control group. The study also aims to establish correlations between these serum levels and the degree of periodontitis severity.
Two groups will be recruited: patients diagnosed with periodontitis and a control group consisting of individuals without periodontal disease.
The participants will be matched for age, gender, and other relevant demographic factors to minimize confounding variables.
Serum samples will be collected from both groups. Periodontitis severity will be determined using established clinical indices, such as probing depth, clinical attachment loss, and bleeding on probing.
Vitamin D levels in the serum will be measured using standardized laboratory techniques.
IL8 levels in the serum will also be quantified using appropriate assays. Statistical analyses will be performed to identify any significant correlations between vitamin D levels, IL8 levels, and the severity of periodontitis.
Subgroup analyses may be conducted to explore potential variations based on demographic factors or other relevant variables.
The study will adhere to ethical guidelines, ensuring participant confidentiality, informed consent, and responsible data handling.
The study anticipates finding associations or correlations between serum levels of vitamin D and IL8 and the severity of periodontitis. This information may contribute to a better understanding of the role of these factors in periodontal health and could have implications for future preventive and therapeutic strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Diagnostic Test: Evalution of serum levels of vitamin D and IL8Individuals diagnosed with periodontitis based on established clinical criteria. This group will include participants who exhibit signs and symptoms of periodontal disease, such as probing depth, clinical attachment loss, and bleeding on probing. |
| Control | – | Diagnostic Test: Evalution of serum levels of vitamin D and IL8Individuals without any signs or history of periodontal disease. This group will consist of participants who do not have clinically diagnosed periodontitis and serve as the healthy control group for comparison with the periodontitis group. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Periodontitis Group: Individuals diagnosed with periodontitis, meet specific criteria such as a minimum of 40% of sites with CAL ≥2 mm, PD ≥4 mm, and ≥40% of sites with bleeding on probing. This group represented individuals with varying degrees of periodontal disease. Control Group: Healthy individuals, age, and gender-matched, devoid of systemic diseases, and medications, and with no sites exhibiting PD ≥4 mm or CAL ≥4 mm. This group provided a baseline for periodontal health in the absence of diagnosed periodontitis. The study's observational design allowed for the comprehensive examination of these groups, shedding light on the interplay between serum biomarkers, vitamin D, IL8, and periodontal health in a real-world setting. Population diversity enhances the generalizability of findings beyond specific clinical or demographic subsets.
Key inclusion criteria (4 listed)
- presence of at least twenty teeth.
- Periodontitis patients with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2 mm and probing depth (PD)≥4 mm.
- presence of ≥40% sites with bleeding on probing.
- Healthy individuals matched for age and gender, who presented no systemic disease, no drugs were taken, no sites with PD ≥4 mm or CAL ≥4 mm, or radiographic signs of bone loss were enrolled, such as a control group.
Key exclusion criteria (7 listed)
- Intake of contraceptives, immunosuppressive, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study.
- Pregnant and lactating females.
- Diabetic patients.
- History of medications that might affect bone and mineral metabolism and/or periodontal health.
- Taking multivitamins and food supplement which contain vitamin D.
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 |
|---|---|---|
| Evalution of serum levels of vitamin D and IL8Group 1 (Periodontitis Group): The intervention involves observing and analyzing individuals diagnosed with periodontitis based on established clinical criteria. The focus is on assessing vitamin D and IL8 levels in the serum and correlating these levels with the severity of periodontitis, determined by clinical indices such as probing depth, clinical attachment loss, and bleeding on probing. Group 2 (Control Group): The intervention involves observing and analyzing individuals without any signs or history of periodontal disease. The focus is on assessing vitamin D and IL8 levels in the serum for comparison with the periodontitis group. This group serves as the healthy control for the study. | Diagnostic test | Control, Periodontitis |
Primary outcome
Serum Levels of 25(OH)vitamin D
Time frame: Laboratory evaluation after samples collection. it was performed in 1 month
Measurement of vitamin D levels (categorized as deficient, inadequate, or adequate) using a commercial ELISA kit.
Serum Levels of IL8
Time frame: Laboratory evaluation after samples collection. it was performed in 1 month
Measurement of IL8 levels (expressed in pg/ml) using a commercial ELISA kit.
3 secondary outcomes
Plaque Index (Pl)
Time frame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Clinical Attachment Loss (CAL)
Time frame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
Probing Pocket Depth (PPD)
Time frame: 1 day (Periodontal evaluation was performed one time for every patient with withdrawal of blood sample)
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 12 Mar 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.
Wafaa saleh, Ph.D principal investigator
Mansoura University, Faculty of Dentistry
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 Mansoura University at 1 site in Egypt.
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 4 inclusion and 7 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 12 Mar 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 Egypt. 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?
Serum Levels of 25(OH)vitamin D (time frame: Laboratory evaluation after samples collection. it was performed in 1 month). The study lists 2 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 12 Mar 2024.