Periodontal DiseasesNCT03727035
Quantification of CD163 Inflammatory Biomarker in Chronic Periodontitis and Diabetic Subjects
An observational study of Periodontal Diseases, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontal Diseases
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 10 Feb 2018to 15 Dec 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 30 to 65 years
- All sexes
- Adult, Older adult
Study population: All patients within the age group of 35-60 years. The subjects were from the South Indian population.
Who may be able to join
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years (both male and female)
- Patients should have ≥ 10 natural teeth.
- Criteria for selection of generalized chronic periodontitis:
- Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.
- Criteria for selection of type II diabetes mellitus:
- Patients having HbA1C <7
Who cannot join
- Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
- Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
- Current smokers, individuals who quit smoking less than 6 months.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Pregnant women (which may alter the oral flora).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Jaideep Mahendra
Chennai, Tamil Nadu, 600095
Jaideep Mahendra, MDS;PhD, 9444963973 ext. 9444963973, jaideep_m_23@yahoo.co.in
Daliah Ruth, BDS, 9789772881, daliah02ruth@gmail.com
About this study
Official title: Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.
Read the detailed description
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.
- Conditions
- Periodontal Diseases
- Keywords
- CD163, Chronic periodontitis
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Group I :40 Generalized chronic periodontitis subjects without type II diabetes mellitus | |
| Group II | Group II: 40 Generalized chronic periodontitis subjects diagnosed with type II diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of CD163 gene
Expression of CD163 gene using RT-PCR
Measured: 12 months
Secondary outcomes (1)
Quantify the levels of CD163
Quantify the levels of CD163 using ELISA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start10 Feb 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
- Investigators
- Jaideep Mahendra, MDS,PhD, Study director, Meenakshi Ammal Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727035
- Sponsor's protocol ID
- MADC/IRB-XV/2017/302
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2018
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Detzen L, Chen SCY, Cheng B, Papapanou PN, Lalla E. Increased levels of soluble CD163 in periodontitis patients. J Clin Periodontol. 2017 Jun;44(6):585-590. doi: 10.1111/jcpe.12731. Epub 2017 May 16.
PubMed 28419494
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03727035
- Acronym / sponsor ID
- MADC/IRB-XV/2017/302
- Conditions
- Periodontal Diseases
- Keywords
- CD163, Chronic periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 1 Nov 2018 (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 quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.
Detailed description
The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Group I :40 Generalized chronic periodontitis subjects without type II diabetes mellitus |
| Group II | – | –Group II: 40 Generalized chronic periodontitis subjects diagnosed with type II diabetes mellitus |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients within the age group of 35-60 years. The subjects were from the South Indian population.
Key inclusion criteria (7 listed)
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years (both male and female)
- Patients should have ≥ 10 natural teeth.
- Criteria for selection of generalized chronic periodontitis:
- Criteria for selection of type II diabetes mellitus:
Key exclusion criteria (5 listed)
- Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
- Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
- Current smokers, individuals who quit smoking less than 6 months.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Pregnant women (which may alter the oral flora).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of CD163 gene
Time frame: 12 months
Expression of CD163 gene using RT-PCR
1 secondary outcome
Quantify the levels of CD163
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Background: PubMed 28419494Detzen L, Chen SCY, Cheng B, Papapanou PN, Lalla E. Increased levels of soluble CD163 in periodontitis patients. J Clin Periodontol. 2017 Jun;44(6):585-590. doi: 10.1111/jcpe.12731. Epub 2017 May 16.
- 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.
Jaideep Mahendra, MDS,PhD study director
Meenakshi Ammal Dental College
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 Meenakshi Ammal Dental College and Hospital at 1 site in India.
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 7 inclusion and 5 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 Oct 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 India. 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 Jaideep Mahendra, MDS;PhD (9444963973, jaideep_m_23@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of CD163 gene (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727035, which also lists 1 linked publication.
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 Oct 2019.