Periodontitis and Rheumatoid ArthritisNCT03995615
ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40
A study testing scaling and root planing in people with Periodontitis and Rheumatoid Arthritis, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis and Rheumatoid Arthritis
- What is being tested?
- scaling and root planing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2020to Oct 2021
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Age group of 25 to 55 years. 2. Patient diagnosed with active rheumatoid arthritis with DAS scoring between ≥3.2 to ≤5.1 3. Patient with generalized mild to moderate chronic periodontitis. 4. Patient who had not received any periodontal treatment in last six months. 5. Dentition with at least twenty functioning teeth. 6. Patient who are co-operative and able to attend follow-up.
Who cannot join
- 1. Any systemic diseased such as diabetic mellitus and thyroid diseases. 2. Former and current smokers. 3. Pregnant and lactating females. 4. Usage of antibiotics or patients on Diseases Modifying Anti-Rheumatic Drugs (DMARD) that affects the periodontal status in the last six months.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
MLV Prabhuji, +919448057407, mlvprabhuji@gmail.com
About this study
Official title: To Estimate the Levels of Gingival Crevicular Fluid YKL-40 in Patients With Healthy Periodontium, Chronic Periodontitis and Chronic Periodontitis With Rheumatoid Arthritis Following Scaling and Root Planing A Clinico-biochemical Study
The presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the conditions.
Read the detailed description
Periodontal diseases is a chronic inflammatory diseases initiated by microbial infection that leads to a host response resulting in inflammatory breakdown of tooth supporting, osseous and soft tissue structures YKL-40 also called as human cartilage glycoprotein-39(HC-gp39), an acute phase protein is a novel potential bio marker in relation to both acute and chronic inflammations. YKL-40 is a member of "mammalian chitinase- like protein" but has no chitinase/ enzymatic activity, with molecular weight of approximately 40KDa. It is named from three amino acids of Tyrosine (Y), Lysine (K) and leucin (L) at the N-terminal YKL-40 was identified in gingival crevicular fluid (GCF) and serum among gingivitis and periodontitis individual with or without diabetic mellitus. Investigation was done in association between chronic periodontitis and diabetic mellitus in gingival crevicular fluid sample. However, the past studies have reported an increased prevalence of rheumatoid arthritis in patient with periodontal diseases. They have reported the presence of rheumatoid factor in gingiva, sub gingival plaque, saliva and serum of periodontally diseased patient. Treatment of periodontal disease has demonstrated significant reduction in erythrocyte sedimentation rate (ESR) which in turn have showed improvement of clinical indices on rheumatoid arthritis activity.we speculate that presence of YKL 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the condition
- Conditions
- Periodontitis and Rheumatoid Arthritis
- Being tested
- scaling and root planing
- Medical subject headings
- Periodontitis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
- After initial clinical evaluation, supra gingival calculus removal will be done. GCF samples will be collected from the control and test groups (Baseline samples) using paper strips (ORAFLOW). ® Group III patients will undergo a through oral hygiene instructions, full mouth supra-gingival and sub- gingival scaling and root planing clinical parameters will be re-recorded 6 weeks later and a 2nd GCF samples will be collected from selected test site from each patients following periodontal intervention.
- All the samples will be placed in eppendorf vials containing the buffer solution and samples will be stored at -800 c until the time of analysis by Enzyme -linked immune sorbent assay kit (ELISA) (GENX BIO) TM
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control) | No intervention | • Group I (Control) - 15 periodontally healthy patient with probing depth< 3mm and ≤ 10% sites with bleeding on probing. |
| • Group II | No intervention | • Group II - 15 systemically healthy chronic periodontitis patient who had presented >25% of sites with gingival bleeding ,surface demonstrating supra-gingival plaque accumulation and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm |
| • Group III | No intervention | • Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1with out scaling and root planing |
| • Group IV | Active comparator | • Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed Receives: Procedure: scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of YKL40 IN GCF
To estimate the levels of gingival crevicular fluid YKL-40 in patients with healthy periodontium, chronic periodontitis and chronic periodontitis with rheumatoid arthritis following scaling and root planing
Measured: 6 WEEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study startJan 2020 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis and Rheumatoid ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Group I (Control) - 15 periodontally healthy patient with probing depth\< 3mm * Group II - 15 systemically healthy chronic periodontitis patient who had \>25% of sites with gingival bleeding and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm * Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1with out scaling and root planing. * Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- RUDRAKSHI C, MDS, Principal investigator, Krishnadevaraya college of dental sciences , Banglore ,KARNATAKA , INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995615
- Sponsor's protocol ID
- 02_D012_91499
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are personal informations of patients and its confidential .
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Estimate the Levels of Gingival Crevicular Fluid YKL-40 in Patients With Healthy Periodontium, Chronic Periodontitis and Chronic Periodontitis With Rheumatoid Arthritis Following Scaling and Root Planing A Clinico-biochemical Study
- ClinicalTrials.gov ID
- NCT03995615
- Acronym / sponsor ID
- 02_D012_91499
- Conditions
- Periodontitis and Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 24 Jun 2019 (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 presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the conditions.
Detailed description
Periodontal diseases is a chronic inflammatory diseases initiated by microbial infection that leads to a host response resulting in inflammatory breakdown of tooth supporting, osseous and soft tissue structures YKL-40 also called as human cartilage glycoprotein-39(HC-gp39), an acute phase protein is a novel potential bio marker in relation to both acute and chronic inflammations. YKL-40 is a member of "mammalian chitinase- like protein" but has no chitinase/ enzymatic activity, with molecular weight of approximately 40KDa. It is named from three amino acids of Tyrosine (Y), Lysine (K) and leucin (L) at the N-terminal YKL-40 was identified in gingival crevicular fluid (GCF) and serum among gingivitis and periodontitis individual with or without diabetic mellitus. Investigation was done in association between chronic periodontitis and diabetic mellitus in gingival crevicular fluid sample. However, the past studies have reported an increased prevalence of rheumatoid arthritis in patient with periodontal diseases. They have reported the presence of rheumatoid factor in gingiva, sub gingival plaque, saliva and serum of periodontally diseased patient. Treatment of periodontal disease has demonstrated significant reduction in erythrocyte sedimentation rate (ESR) which in turn have showed improvement of clinical indices on rheumatoid arthritis activity.we speculate that presence of YKL 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the condition
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- * Group I (Control) - 15 periodontally healthy patient with probing depth< 3mm * Group II - 15 systemically healthy chronic periodontitis patient who had >25% of sites with gingival bleeding and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm * Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1with out scaling and root planing. * Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Group I (Control) | No intervention | –• Group I (Control) - 15 periodontally healthy patient with probing depth< 3mm and ≤ 10% sites with bleeding on probing. |
| • Group II | No intervention | –• Group II - 15 systemically healthy chronic periodontitis patient who had presented >25% of sites with gingival bleeding ,surface demonstrating supra-gingival plaque accumulation and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm |
| • Group III | No intervention | –• Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1with out scaling and root planing |
| • Group IV | Active comparator | Procedure: scaling and root planing• Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28[DAS-28] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age group of 25 to 55 years. 2. Patient diagnosed with active rheumatoid arthritis with DAS scoring between ≥3.2 to ≤5.1 3. Patient with generalized mild to moderate chronic periodontitis. 4. Patient who had not received any periodontal treatment in last six months. 5. Dentition with at least twenty functioning teeth. 6. Patient who are co-operative and able to attend follow-up.
Key exclusion criteria (1 listed)
- 1. Any systemic diseased such as diabetic mellitus and thyroid diseases. 2. Former and current smokers. 3. Pregnant and lactating females. 4. Usage of antibiotics or patients on Diseases Modifying Anti-Rheumatic Drugs (DMARD) that affects the periodontal status in the last six months.
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 |
|---|---|---|
| scaling and root planing* After initial clinical evaluation, supra gingival calculus removal will be done. GCF samples will be collected from the control and test groups (Baseline samples) using paper strips (ORAFLOW). ® Group III patients will undergo a through oral hygiene instructions, full mouth supra-gingival and sub- gingival scaling and root planing clinical parameters will be re-recorded 6 weeks later and a 2nd GCF samples will be collected from selected test site from each patients following periodontal intervention. * All the samples will be placed in eppendorf vials containing the buffer solution and samples will be stored at -800 c until the time of analysis by Enzyme -linked immune sorbent assay kit (ELISA) (GENX BIO) TM | Procedure or surgery | • Group IV |
Primary outcome
levels of YKL40 IN GCF
Time frame: 6 WEEEKS
To estimate the levels of gingival crevicular fluid YKL-40 in patients with healthy periodontium, chronic periodontitis and chronic periodontitis with rheumatoid arthritis following scaling and root planing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: No. IPD are personal informations of patients and its confidential .
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.
RUDRAKSHI C, MDS principal investigator
Krishnadevaraya college of dental sciences , Banglore ,KARNATAKA , INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and root planing in people with Periodontitis and Rheumatoid Arthritis, run by Krishnadevaraya College of Dental Sciences & 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 1 inclusion and 1 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 Jun 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 RUDRAKSHI C, MDS (28467083 ext. 080, drrudrakshi@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of YKL40 IN GCF (time frame: 6 WEEEKS). 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 Jun 2019.