Hyperlipidemia, Periodontitis, GingivitisNCT02808130
PERIODONTAL DISEASE AND HYPERLIPIDEMIA
An observational study of Hyperlipidemia, Periodontitis, Gingivitis, run by Ondokuz Mayıs University.
Trial summary
The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein subfractions have deleterious impact on the development of periodontal infection by altering oxidative stres status of periodontal tissues. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Periodontitis, Gingivitis
- What is being tested?
- hyperlipidemia, periodontitis, gingivitis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: An observational case-control study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healhy controls.
Who may be able to join
- ≥ 18 years of age and having ≥ 16 teeth; (ii)no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection and any anti-lipaemic drug treatment; (iv) no previous history of smoking.
Who cannot join
- medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism(i.e. impaired glucose tolerance, metabolic syndrome); (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; and (vi) dental treatment during the 6 months prior to data collection.
- -
About this study
Official title: A CASE CONTROL STUDY TO DETERMINE THE GINGIVAL CREVICULAR FLUID MALONDIALDEHYDE, PROTEIN CARBONYL AND TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA
The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein subfractions have deleterious impact on the development of periodontal infection by altering oxidative stres status of periodontal tissues. The aim of this study was therefore to investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and TAOC levels in patients with different periodontal status,
Read the detailed description
An observational study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healthy controls. The participants were recruited as a joint collaboration between Periodontology Department of the Faculty of Dentistry and the Endocrinology and Metabolic Diseases Department of the Faculty of Medicine at Ondokuz Mayis University in Samsun, Turkey between january 2013 and august 2014.The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000) It has been asserted that elevated serum lipid levels create a pro-inflammatory state, which leads to an increase in oxidative state by composing an imbalanced production between highly reactive molecular species and antioxidant defences, consequently predisposing one to infections. Hyperlipidemia claimed to lead an increase in production of reactive oxygen species (ROS) and lipid peroxidation (LPO). On the other hand it has been suggested that high-cholesterol diet increases OS and causes oxidative damage in various organs. Also, OS related mediators have frequently shown to be associated with chronic periodontitis (CP) related inflammatory responses . Excessive ROS derived radical formations reported to have an important role in the inflammatory process by leading to damage to proteins, DNA, carbohydrates, and lipids.
Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl).
Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index ; Löe \& Silness gingival index ; Probing pocket dept,clinical attachment level, bleeding on probing (BOP) measurements were performed on 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) using a Williams periodontal probe. GCF collection was subsequently performed using those sites that fit the criteria for GCF sampling described below.
All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the deepest 6 sites in the chronic periodontitis group. In the gingivitis group samples were collected from the teeth with bleeding on probing, whereas teeth without BOP were chosen in the healthy group. GCF samples were collected from the similar 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling. Accordingly, total of 90 GCF samples were taken from each of the 6 groups (15 individuals per group x 6 sites).
- Being tested
- hyperlipidemia, periodontitis, gingivitis
- Keywords
- hyperlipidemia, periodontal disease, oxidative stress,
- Medical subject headings
- Hyperlipidemias, Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperlipidemia, periodontitis, gingivitisOther
GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva
| Study group | Role | What they receive |
|---|---|---|
| group H | Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. Receives: Other: hyperlipidemia, periodontitis, gingivitis | |
| Group G | Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions Receives: Other: hyperlipidemia, periodontitis, gingivitis | |
| Group CP | Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions Receives: Other: hyperlipidemia, periodontitis, gingivitis | |
| Group HH | Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. Receives: Other: hyperlipidemia, periodontitis, gingivitis | |
| Group HG | Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. Receives: Other: hyperlipidemia, periodontitis, gingivitis | |
| group HCP | Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions Receives: Other: hyperlipidemia, periodontitis, gingivitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation
Measured: 8-10 am on the day following periodontal status assessment.
Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation
Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.
Measured: 8-10 am on the day following periodontal status assessment.
Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status
Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules
Measured: 8-10 am on the day following periodontal status assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperlipidemia, Periodontitis, GingivitisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muge lutfioglu, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808130
- Sponsor's protocol ID
- OMU KAEK 2012/43-0.06.12
- Status last verified
- Aug 2016
- First submitted
- 17 Jun 2016
- Last updated
- 21 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CASE CONTROL STUDY TO DETERMINE THE GINGIVAL CREVICULAR FLUID MALONDIALDEHYDE, PROTEIN CARBONYL AND TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA
- ClinicalTrials.gov ID
- NCT02808130
- Acronym / sponsor ID
- OMU KAEK 2012/43-0.06.12
- Keywords
- hyperlipidemia, periodontal disease, oxidative stress,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 21 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein subfractions have deleterious impact on the development of periodontal infection by altering oxidative stres status of periodontal tissues. The aim of this study was therefore to investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and TAOC levels in patients with different periodontal status,
Detailed description
An observational study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healthy controls. The participants were recruited as a joint collaboration between Periodontology Department of the Faculty of Dentistry and the Endocrinology and Metabolic Diseases Department of the Faculty of Medicine at Ondokuz Mayis University in Samsun, Turkey between january 2013 and august 2014.The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000) It has been asserted that elevated serum lipid levels create a pro-inflammatory state, which leads to an increase in oxidative state by composing an imbalanced production between highly reactive molecular species and antioxidant defences, consequently predisposing one to infections. Hyperlipidemia claimed to lead an increase in production of reactive oxygen species (ROS) and lipid peroxidation (LPO). On the other hand it has been suggested that high-cholesterol diet increases OS and causes oxidative damage in various organs. Also, OS related mediators have frequently shown to be associated with chronic periodontitis (CP) related inflammatory responses . Excessive ROS derived radical formations reported to have an important role in the inflammatory process by leading to damage to proteins, DNA, carbohydrates, and lipids.
Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl).
Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index ; Löe \& Silness gingival index ; Probing pocket dept,clinical attachment level, bleeding on probing (BOP) measurements were performed on 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) using a Williams periodontal probe. GCF collection was subsequently performed using those sites that fit the criteria for GCF sampling described below.
All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the deepest 6 sites in the chronic periodontitis group. In the gingivitis group samples were collected from the teeth with bleeding on probing, whereas teeth without BOP were chosen in the healthy group. GCF samples were collected from the similar 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling. Accordingly, total of 90 GCF samples were taken from each of the 6 groups (15 individuals per group x 6 sites).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group H | – | Other: hyperlipidemia, periodontitis, gingivitisGroup H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. |
| Group G | – | Other: hyperlipidemia, periodontitis, gingivitisGroup G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions |
| Group CP | – | Other: hyperlipidemia, periodontitis, gingivitisGroup CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions |
| Group HH | – | Other: hyperlipidemia, periodontitis, gingivitisGroup HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. |
| Group HG | – | Other: hyperlipidemia, periodontitis, gingivitisGroup HG: hyperlipidemic + gingivitis individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. |
| group HCP | – | Other: hyperlipidemia, periodontitis, gingivitisGroup HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- An observational case-control study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healhy controls.
Key inclusion criteria (1 listed)
- ≥ 18 years of age and having ≥ 16 teeth; (ii)no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection and any anti-lipaemic drug treatment; (iv) no previous history of smoking.
Key exclusion criteria (2 listed)
- medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism(i.e. impaired glucose tolerance, metabolic syndrome); (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; and (vi) dental treatment during the 6 months prior to data collection.
- -
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 |
|---|---|---|
| hyperlipidemia, periodontitis, gingivitisGCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva | Other | Group CP, Group G, Group HG, Group HH, group H, group HCP |
Primary outcome
Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.
Time frame: 8-10 am on the day following periodontal status assessment.
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation
Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation
Time frame: 8-10 am on the day following periodontal status assessment.
Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.
Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status
Time frame: 8-10 am on the day following periodontal status assessment.
Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, Periodontitis, Gingivitis, run by Ondokuz Mayıs University.
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 1 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 21 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation. (time frame: 8-10 am on the day following periodontal status assessment.). The study lists 3 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 21 Sep 2016.