Periodontal InflammationNCT04201912
Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients
A study testing saliva analysis for Toll like receptor activity in people with Periodontal Inflammation, run by Ajman University at 1 site in United Arab Emirates.
Trial summary
In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms . Periodontal disease is mixed infection resulting due to dysbiosis . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Inflammation
- What is being tested?
- saliva analysis for Toll like receptor activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 May 2019to 1 Sep 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- *Untreated stage 2 periodontitis patients (n-60)-Age group 21-60
- Non Smokers
- Diabetic patients controlled
- Not haven taken medications in the past 3 months
Who cannot join
- smoker
- habits such as betel, tobacco chewing
- systemically unstable, Diabetes uncontrolled patients
- haven taken medications in the past 3 months
- Pregnant ladies
- Periodontal involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients With and Without Type 2 Diabetes
In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms . Periodontal disease is mixed infection resulting due to dysbiosis . When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers . Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.
Read the detailed description
In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms. Periodontal disease is mixed infection resulting due to dysbiosis. When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers. Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.
Periodontal diseases are classified according to the American academy of periodontology as stage 1, 2, 3\&4 according to severity and extent of the disease progression.
Stage 2 periodontitis was selected as it is considered as an intermediary, because CAL(clinical attachment loss was standardized at 3-4mm,this could reflect the progression of disease and its impact from a horizontal bone loss to a more oblique one, if in case the dysbiosis persists.
- Conditions
- Periodontal Inflammation
- Being tested
- saliva analysis for Toll like receptor activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva analysis for Toll like receptor activityDiagnostic test
Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity
| Study group | Role | What they receive |
|---|---|---|
| control patients | Placebo comparator | Evaluation of Toll like receptor activity from whole saliva obtained from control patients Receives: Diagnostic Test: saliva analysis for Toll like receptor activity |
| Periodontal patients without diabetes | Active comparator | Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes Receives: Diagnostic Test: saliva analysis for Toll like receptor activity |
| Periodontal patients with diabetes | Active comparator | Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes Receives: Diagnostic Test: saliva analysis for Toll like receptor activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toll like receptor 2 activity
Toll like receptor 2 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes
Measured: From baseline to 5 months
Secondary outcomes (1)
Toll like receptor 4 activity
Toll like receptor 4 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes
Measured: From baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 May 2019
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Selection of patients by grading the patients according to criteria patients without periodontal and systemic involvement(control), patients classified as stage 2 periodontitis without systemic involvement(test group1), patients classified as stage 2 Periodontitis with systemic disease(Type 2 diabetes)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201912
- Sponsor's protocol ID
- D-F-19-03-03
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04201912
- Acronym / sponsor ID
- D-F-19-03-03
- Conditions
- Periodontal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 Dec 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.
In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms . Periodontal disease is mixed infection resulting due to dysbiosis . When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers . Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.
Detailed description
In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms. Periodontal disease is mixed infection resulting due to dysbiosis. When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers. Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.
Periodontal diseases are classified according to the American academy of periodontology as stage 1, 2, 3\&4 according to severity and extent of the disease progression.
Stage 2 periodontitis was selected as it is considered as an intermediary, because CAL(clinical attachment loss was standardized at 3-4mm,this could reflect the progression of disease and its impact from a horizontal bone loss to a more oblique one, if in case the dysbiosis persists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Selection of patients by grading the patients according to criteria patients without periodontal and systemic involvement(control), patients classified as stage 2 periodontitis without systemic involvement(test group1), patients classified as stage 2 Periodontitis with systemic disease(Type 2 diabetes)
| Arm | Type | Receives |
|---|---|---|
| control patients | Placebo comparator | Diagnostic Test: saliva analysis for Toll like receptor activityEvaluation of Toll like receptor activity from whole saliva obtained from control patients |
| Periodontal patients without diabetes | Active comparator | Diagnostic Test: saliva analysis for Toll like receptor activityEvaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes |
| Periodontal patients with diabetes | Active comparator | Diagnostic Test: saliva analysis for Toll like receptor activityEvaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- *Untreated stage 2 periodontitis patients (n-60)-Age group 21-60
Key exclusion criteria (6 listed)
- smoker
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 |
|---|---|---|
| saliva analysis for Toll like receptor activityStimulated whole saliva will be obtained from patients and tested for Toll like receptor activity | Diagnostic test | Periodontal patients with diabetes, Periodontal patients without diabetes, control patients |
Primary outcome
Toll like receptor 2 activity
Time frame: From baseline to 5 months
Toll like receptor 2 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes
1 secondary outcome
Toll like receptor 4 activity
Time frame: From baseline to 5 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 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saliva analysis for Toll like receptor activity in people with Periodontal Inflammation, run by Ajman University at 1 site in United Arab Emirates.
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 4 inclusion and 6 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 18 Dec 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 United Arab Emirates. 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. Some participants in this study may receive a placebo. 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?
Toll like receptor 2 activity (time frame: From baseline to 5 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 18 Dec 2019.