Periodontitis, Rheumatoid Arthritis, Autoimmunity,NCT02577679
Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease
An observational study of Periodontitis, Rheumatoid Arthritis, Autoimmunity,, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Rheumatoid Arthritis, Autoimmunity,
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to Nov 2015
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physically healthy persons, especially free of any autoimmune diseases, DM, CVD. No history of periodontal treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.
Read the detailed description
In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.
- Keywords
- Dentistry
- Medical subject headings
- Periodontitis, Arthritis, Rheumatoid, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of anti-cyclic citrullinated peptide/protein antibody
Lower then 7 Unit/milliliter: negative 7-10 Unit/milliliter: weak positive Higher then 10 Unit/milliliter: positive
Measured: Base line
Periodontal pocket depth and clinical attachment level
Lower then 4 millimeter: normal Higher then 4 millimeter: diseased/previously diseased
Measured: Baseline
Secondary outcomes (4)
Serum level of tumor necrotic factor alpha
Recorded in picogram per milliliter
Measured: Baseline
Serum level of anti-mutated citrullinated vimentin
Recorded in Unit per milliliter
Measured: Baseline
Serum level of interleukin 6
Recorded in picogram per milliliter
Measured: Baseline
Serum level of interleukin 17
Recorded in picogram per milliliter
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, Rheumatoid Arthritis, Autoimmunity,Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Wen Chen, PhD, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577679
- Sponsor's protocol ID
- 201503116RINA
- Status last verified
- Oct 2015
- First submitted
- 23 Sep 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease
- ClinicalTrials.gov ID
- NCT02577679
- Acronym / sponsor ID
- 201503116RINA
- Keywords
- Dentistry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (estimated)
- First posted
- 16 Oct 2015 (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 aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.
Detailed description
In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physically healthy persons, especially free of any autoimmune diseases, DM, CVD. No history of periodontal treatment.
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
Serum level of anti-cyclic citrullinated peptide/protein antibody
Time frame: Base line
Lower then 7 Unit/milliliter: negative 7-10 Unit/milliliter: weak positive Higher then 10 Unit/milliliter: positive
Periodontal pocket depth and clinical attachment level
Time frame: Baseline
Lower then 4 millimeter: normal Higher then 4 millimeter: diseased/previously diseased
4 secondary outcomes
Serum level of tumor necrotic factor alpha
Time frame: Baseline
Serum level of anti-mutated citrullinated vimentin
Time frame: Baseline
Serum level of interleukin 6
Time frame: Baseline
Serum level of interleukin 17
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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.
Yi-Wen Chen, PhD study director
Assistant professor
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 Periodontitis, Rheumatoid Arthritis, Autoimmunity,, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Oct 2015. 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 Taiwan. 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?
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 level of anti-cyclic citrullinated peptide/protein antibody (time frame: Base line). 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 16 Oct 2015.