Chronic PeriodontitisNCT02069574
Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
A study testing non-surgical periodontal therapy in people with Chronic Periodontitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe Periodontal Disease
- Patients with chronic severe periodontitis
- Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
- Moderate Periodontal Disease
- Patients with chronic moderate periodontitis
Show all 11Show fewer
- Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
- Healthy Control
- Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person)
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
Who cannot join
- Received periodontal treatment within the last six months
- recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
- taking the drug can affect periodontal status for a long period of time
- pregnant or breastfeeding
- In case of oral inflammatory mucosal disease (Lichen planus, etc.)
- A history of alcoholism or drug abuse if
- other special systemic disease (high blood pressure)
- ages under 18
Trial locations and contacts
1 site in 1 country.
South Korea1 site
ASAN Medical Center
Seoul, 138-736
Su-Hwan Kim, PhD, 82-2-3010-5797, shkimperio@amc.seoul.kr
Su-Hwan Kim, PhD
About this study
Official title: Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva
The purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. The obtained data will secure the foundation for the development of a new non-invasive diagnostic methods for early diagnosis \& prognosis prediction of periodontal disease.
- Conditions
- Chronic Periodontitis
- Being tested
- non-surgical periodontal therapy
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| severe periodontitis group | Experimental | non-surgical periodontal therapy Receives: Procedure: non-surgical periodontal therapy |
| Moderate periodontitis group | Experimental | non-surgical periodontal therapy Receives: Procedure: non-surgical periodontal therapy |
| healthy control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression level of MicroRNAs using Microarray
Measured: Change from Baseline in expression level of MicroRNAs at 1,6,12 months
Secondary outcomes (1)
Expression level of cytokines using multiple cytokine analysis
- Pro-inflammatory biomarker : interleukin(IL)-1a, IL-1b, IL-6, IL-8
- Matrix metalloproteinase(MMP) : MMP-8, MMP-9
- Anti-inflammatory biomarker: IL-10, inhibitor of MMP (TIMP)-1
Measured: Change from Baseline in expression level of cytokines at 1,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-Hwan Kim, Asan Medical Center
- Investigators
- Su-Hwan Kim, PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069574
- Sponsor's protocol ID
- 2013-0940
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva
- ClinicalTrials.gov ID
- NCT02069574
- Acronym / sponsor ID
- 2013-0940
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- 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 purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. The obtained data will secure the foundation for the development of a new non-invasive diagnostic methods for early diagnosis \& prognosis prediction of periodontal disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| severe periodontitis group | Experimental | Procedure: non-surgical periodontal therapynon-surgical periodontal therapy |
| Moderate periodontitis group | Experimental | Procedure: non-surgical periodontal therapynon-surgical periodontal therapy |
| healthy control | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Severe Periodontal Disease
- Patients with chronic severe periodontitis
- Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
- subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing
- Moderate Periodontal Disease
Key exclusion criteria (8 listed)
- Received periodontal treatment within the last six months
- recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
- taking the drug can affect periodontal status for a long period of time
- pregnant or breastfeeding
- In case of oral inflammatory mucosal disease (Lichen planus, etc.)
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 |
|---|---|---|
| non-surgical periodontal therapy | Procedure or surgery | Moderate periodontitis group, severe periodontitis group |
Primary outcome
Expression level of MicroRNAs using Microarray
Time frame: Change from Baseline in expression level of MicroRNAs at 1,6,12 months
1 secondary outcome
Expression level of cytokines using multiple cytokine analysis
Time frame: Change from Baseline in expression level of cytokines at 1,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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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.
Su-Hwan Kim, PhD. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal therapy in people with Chronic Periodontitis, run by Asan Medical Center at 1 site in South Korea.
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 11 inclusion and 8 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 24 Feb 2014. 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 South Korea. 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 Su-Hwan Kim, PhD. (82-2-3010-5797, shkimperio@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression level of MicroRNAs using Microarray (time frame: Change from Baseline in expression level of MicroRNAs at 1,6,12 months). 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 24 Feb 2014.