Periodontal DiseasesNCT03391349
Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Chronic Periodontitis and Diabetic Subjects
An observational study of Periodontal Diseases, run by Meenakshi Ammal Dental College and Hospital.
Trial summary
The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.The demographic and the periodontal parameters were assessed and the correlated with the quantification of… Read more about this study
- Who is it for?
- Ages 35 to 60 years, men only
- Conditions the study is for
- Periodontal Diseases
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2016to 1 Dec 2017
- 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 35 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: All male 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.
- Male patients within the age group 35 to 60 years.
- Patients having ≥ 10 natural teeth.
- No history of long term antibiotic use in the past 6 months and no history of diabetes mellitus.
- For Group I:
- Generalized severe chronic periodontitis subjects (30% or more sites with clinical attachment loss (CAL) ≥ 5mm) without type II diabetes mellitus.
- For Group II:
- Generalized severe chronic periodontitis subjects (30% or more sites with clinical attachment loss (CAL) ≥ 5mm) diagnosed with type II diabetes mellitus (HbA1C levels ≥7%) for the past 5 years and is under oral medication.
Who cannot join
- Patients with systemic conditions, such as cardiovascular and respiratory diseases, HIV infection, immunosuppressive patients and patients under chemotherapy.
- Smokers and other behavioral factors which may influence the study.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Female patients (due to hormonal changes and pregnancy which may alter the oral flora).
- -
About this study
Official title: Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Subgingival Tissue Samples of Generalized Severe Chronic Periodontitis Patients With and Without Type II Diabetes Mellitus
The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.The demographic and the periodontal parameters were assessed and the correlated with the quantification of the proteins. The mRNA expression was analyzed with RT-PCR and the quantification of protein was done using ELISA.
Read the detailed description
The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.A total of 70 subjects with generalized severe chronic periodontitis were selected and divided into two groups. Group I comprised of 35 subjects who were diagnosed with generalized severe chronic periodontitis without any systemic conditions. Group II comprised of generalized severe 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 tissue samples were collected from both the groups from the periodontal surgical site. The collected samples were subjected to further molecular analysis for the mRNA expression of L-plastin, lipocalin and adiponectin using RT-PCR and for their protein quantification using ELISA.The elevated levels of mRNA expression and elevated quantification of L-plastin and Lipocalin proteins in the subgingival tissue samples of generalized severe chronic periodontitis subjects with diabetes denoted the localized involvement of these molecules in the pathogenesis of both periodontitis and type II diabetes mellitus. Since adiponectin was reduced in periodontitis patients with type II diabetes mellitus, it can be used as an anti-inflammatory and anti-diabetic biomarker for the early identification of patients at risk for diabetes mellitus and periodontitis.
- Conditions
- Periodontal Diseases
- Keywords
- proteomes, 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: 35 generalized severe chronic periodontitis subjects without type II diabetes mellitus and systemically healthy. | |
| Group II | GROUP II: 35 generalized severe 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.
mRNA expression of L-plastin,lipocalin and adiponection
mRNA expression of L-plastin,lipocalin and adiponectin using Real Time PCR
Measured: 9 months
Secondary outcomes (1)
Quantify the levels of L-plastin, lipocalin and adiponectin
Quantify levels of L-plastin, lipocalin and adiponectin using ELISA.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start20 Oct 2016
- Primary completion22 Jul 2017
- Study completion1 Dec 2017
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
- 70 participants (actual)
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
- NCT03391349
- Sponsor's protocol ID
- MADC/IRB-IX/2016/151
- Status last verified
- Dec 2017
- First submitted
- 21 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk VO, Emingil G, Osterwalder V, Bostanci N. The actin-bundling protein L-plastin: a novel local inflammatory marker associated with periodontitis. J Periodontal Res. 2015 Jun;50(3):337-46. doi: 10.1111/jre.12212. Epub 2014 Jul 12.
PubMed 25040533
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Subgingival Tissue Samples of Generalized Severe Chronic Periodontitis Patients With and Without Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03391349
- Acronym / sponsor ID
- MADC/IRB-IX/2016/151
- Conditions
- Periodontal Diseases
- Keywords
- proteomes, chronic periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 22 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 5 Jan 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 the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.The demographic and the periodontal parameters were assessed and the correlated with the quantification of the proteins. The mRNA expression was analyzed with RT-PCR and the quantification of protein was done using ELISA.
Detailed description
The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in the subgingival tissue samples of generalized severe chronic periodontitis patients with and without diabetes mellitus.A total of 70 subjects with generalized severe chronic periodontitis were selected and divided into two groups. Group I comprised of 35 subjects who were diagnosed with generalized severe chronic periodontitis without any systemic conditions. Group II comprised of generalized severe 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 tissue samples were collected from both the groups from the periodontal surgical site. The collected samples were subjected to further molecular analysis for the mRNA expression of L-plastin, lipocalin and adiponectin using RT-PCR and for their protein quantification using ELISA.The elevated levels of mRNA expression and elevated quantification of L-plastin and Lipocalin proteins in the subgingival tissue samples of generalized severe chronic periodontitis subjects with diabetes denoted the localized involvement of these molecules in the pathogenesis of both periodontitis and type II diabetes mellitus. Since adiponectin was reduced in periodontitis patients with type II diabetes mellitus, it can be used as an anti-inflammatory and anti-diabetic biomarker for 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: 35 generalized severe chronic periodontitis subjects without type II diabetes mellitus and systemically healthy. |
| Group II | – | –GROUP II: 35 generalized severe chronic periodontitis subjects diagnosed with type II diabetes mellitus. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All male patients within the age group of 35-60 years. The subjects were from the South Indian population.
Key inclusion criteria (8 listed)
- Patients willing to participate in the study.
- Male patients within the age group 35 to 60 years.
- Patients having ≥ 10 natural teeth.
- No history of long term antibiotic use in the past 6 months and no history of diabetes mellitus.
- Generalized severe chronic periodontitis subjects (30% or more sites with clinical attachment loss (CAL) ≥ 5mm) without type II diabetes mellitus.
Key exclusion criteria (5 listed)
- Patients with systemic conditions, such as cardiovascular and respiratory diseases, HIV infection, immunosuppressive patients and patients under chemotherapy.
- Smokers and other behavioral factors which may influence the study.
- Patients who had undergone periodontal therapy within the previous 6 months.
- Female patients (due to hormonal changes and pregnancy 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
mRNA expression of L-plastin,lipocalin and adiponection
Time frame: 9 months
mRNA expression of L-plastin,lipocalin and adiponectin using Real Time PCR
1 secondary outcome
Quantify the levels of L-plastin, lipocalin and adiponectin
Time frame: 9 months
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 5 Jan 2018.
- Background: PubMed 25040533Ozturk VO, Emingil G, Osterwalder V, Bostanci N. The actin-bundling protein L-plastin: a novel local inflammatory marker associated with periodontitis. J Periodontal Res. 2015 Jun;50(3):337-46. doi: 10.1111/jre.12212. Epub 2014 Jul 12.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Meenakshi Ammal Dental College and Hospital.
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 8 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: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
mRNA expression of L-plastin,lipocalin and adiponection (time frame: 9 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 NCT03391349, 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 5 Jan 2018.