Periodontal DiseaseNCT03775967
Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
An observational study of Periodontal Disease, run by Ajman University at 1 site in India.
Trial summary
Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- sialic acid and IL10
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 10 Oct 2018to 10 Feb 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore
Who may be able to join
- All the subjects should be within the age group of 18 to 55 years
- subject should have atleast 18 natural teeth excluding third molars.
Who cannot join
- History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.
- corticosteroids, in previous three months
- systemically compromised individuals
- smokers
- pregnant and lactating women
- Medical history for absence of systemic disorders such as diabetes mellitus
Show all 10Show fewer
- cardiovascular diseases
- pneumonia
- tuberculosis
- rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.
The present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients
Read the detailed description
Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis
Obtaining consent from patients participating in the study
Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.
- Conditions
- Periodontal Disease
- Being tested
- sialic acid, IL10
- Keywords
- sialic acid, IL10, stage 1 periodontal disease, stage 2 periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sialic acidDiagnostic test
sialic acid level estimation in salivary samples
IL10Diagnostic test
IL10 estimation in salivary samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Sialic acid levels in stage 1 periodontitis
Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
Measured: From baseline to 3 months
Sialic acid levels in stage 2 periodontitis
Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
Measured: From baseline to 3 months
IL10 levels in stage 1 periodontitis
IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
Measured: From baseline to 3 months
IL10 levels in stage 2 periodontitis
IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start10 Oct 2018
- Primary completion10 Jan 2019
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- 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
- NCT03775967
- Sponsor's protocol ID
- UGD-H-18-10-31-10
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2018
- Last updated
- 26 Nov 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03775967
- Acronym / sponsor ID
- UGD-H-18-10-31-10
- Conditions
- Periodontal Disease
- Keywords
- sialic acid, IL10, stage 1 periodontal disease, stage 2 periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 14 Dec 2018 (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.
Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.
The present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients
Detailed description
Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis
Obtaining consent from patients participating in the study
Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore
Key inclusion criteria (2 listed)
- All the subjects should be within the age group of 18 to 55 years
- subject should have atleast 18 natural teeth excluding third molars.
Key exclusion criteria (10 listed)
- History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.
- corticosteroids, in previous three months
- systemically compromised individuals
- smokers
- pregnant and lactating women
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 |
|---|---|---|
| sialic acidsialic acid level estimation in salivary samples | Diagnostic test | – |
| IL10IL10 estimation in salivary samples | Diagnostic test | – |
Primary outcome
Sialic acid levels in stage 1 periodontitis
Time frame: From baseline to 3 months
Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
Sialic acid levels in stage 2 periodontitis
Time frame: From baseline to 3 months
Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
IL10 levels in stage 1 periodontitis
Time frame: From baseline to 3 months
IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
IL10 levels in stage 2 periodontitis
Time frame: From baseline to 3 months
IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
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 26 Nov 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?
An observational study of Periodontal Disease, run by Ajman University 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 2 inclusion and 10 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 26 Nov 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?
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?
Sialic acid levels in stage 1 periodontitis (time frame: From baseline to 3 months). The study lists 4 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 26 Nov 2019.