Periodontal DiseasesNCT03510702
SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
An observational study of Periodontal Diseases and Inflammatory Response, run by University of Valencia at 1 site in Spain.
Trial summary
Epigenetics has produced a high impact in biomedical research and is providing new biomarkers for the diagnosis and prognosis of diseases. In addition, epigenetics is also contributing to analyze the molecular causes underlying diseases, even so periodontal diseases as it has been recently reviewed. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Inflammatory Response
- What is being tested?
- Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2017to Jul 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients attending to the university who meet the inclusion criteria.
Who may be able to join
- Group of periodontal patients:
- Clinical criteria: at least 3 locations in unirradicular teeth with PD 6 mm. 3 samples will be taken from each of these 3 locations (9 total samples). Third molars are not included in the study.
- Patients not treated periodontally.
- 30-60 years.
- Periodontally healthy group:
- 1. Absence of clinical and radiographical periodontal pathology.
Who cannot join
- Group of periodontal patients:
- Aggressive Periodontal Disease (Armitage, 1999).
- Patients with controlled periodontal disease with plaque and gingival indexes ≤20%.
- Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressants, etc ...).
- Patients with antibiotic, anti-inflammatory or contraceptive treatment in the previous 3 months or taking antiaggregants in the last 7 days before taking the sample.
- Smokers (> 10 cig. /day).
Show all 12Show fewer
- Pregnant or breast-feeding.
- Periodontally healthy group:
- Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressant...).
- Patients with antibiotic, anti-inflammatory or contraceptive treatment in the previous 3 months or taking antiaggregants in the last 7 days before taking the sample.
- Smokers (> 10 cig/day).
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ana Fuenmayor Garcés
Valencia
Ana Fuenmayor Garcés, Postgraduate student, 0034680964117, anafuenmayorgarces@gmail.com
About this study
Official title: Screening of Epigenetic Biomarkers (miRNA) in the Gingival Sulcus
Epigenetics has produced a high impact in biomedical research and is providing new biomarkers for the diagnosis and prognosis of diseases. In addition, epigenetics is also contributing to analyze the molecular causes underlying diseases, even so periodontal diseases as it has been recently reviewed. In this regard, changes in the methylation of genes codifying for pro-inflammatory and anti-inflammatory cytokines has been previously reported. miRNAs are very promising biomolecules to be used as biomarkers because miRNAs act as signaling molecules and participate in many biological processes, such as cellular development, differentiation, and apoptosis. The high stability of circulating miRNAs in the RNase-rich environment of the bloodstream and also in different biospecimens used in clinical routine, make these biomolecules an optimal source of candidate biomarkers. In fact, miRNAs have demonstrated their value as dynamic biomarkers in a wide variety of human diseases. Therefore, miRNAs can be used for the monitoring of periodontal disease.
The objective of this research is to analyze the levels of bone remodeling RANKL / OPG biomolecular markers, and the epigenetic regulation of these proteins to identify promising biomarkers of periodontal disease.
Read more
Material and Methods. Levels of RANKL and OPG will be measured in the gingival crevicular fluid (GCF) to assess the state of bone. These samples will be sent to the lab for quantification by ELISA method.
Furthermore, new epigenetic biomarkers based on the identification of high stable microRNAs will be identified by qRT-PCR in GCF as feasible tools for diagnosis and monitoring of wide range of disease, including periodontal disease.
- Conditions
- Periodontal Diseases, Inflammatory Response
- Being tested
- Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.
- Keywords
- Epigenetic., microRNA., Periodontitis.
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.Diagnostic test
Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken.
Subsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal patients. | Taking gingival Crevicular fluid. Receives: Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism. | |
| Periodontally healthy patients. | Taking gingival Crevicular fluid. Receives: Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA in gingival crevicular fluid (physiological parameter).
Insert the Perio Paper® tip in gingival sulcus until resistance is felt and leave it for 30 seconds.
Measured: 2 years.
Secondary outcomes (6)
Probing depth.
Probing depth will be measured in six sites (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal) of every teeth with a Williams Probe PQ-OW 208 396. This probe is used by gently hanging pressure into a pocket measuring 20 grams in weight.
Measured: 2 years.
Bleeding on probing.
Full mouth bleeding score (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing for PD. The usual thing to do is to measure at 4 points for each tooth but we have modified the index and we valorate them at 6 points. (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal).
Measured: 2 years.
Clinical recession.
Clinical recession will be measured in the same six sites as before between the Amelocemental junction and the gingival margin.
Measured: 2 years.
Plaque score of Silness y löe: (1964)
The Plaque will be scored as follows:
Score 0 = No plaque
Score 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
Score 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye.
Score 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The usual thing to do is to evaluate at 4 points for each tooth but we have modified the index and we will evaluate at 6 points. (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal)
Measured: 2 years.
Dental movility of Mïller 1950
Class I
Up to 1 mm of movement in a horizontal direction.
Class II Greater than 1 mm of movement in a horizontal direction. Class III
Excessive horizontal movement and vertical movement.
Measured: 2 years.
Furcation affection.
Class I:
The level of bone loss allows for the insertion of the periodontal Nabers probe into the concavity of the root trunk. Furcation defect is less than 3 mm is depth.
Class II The level of bone loss allows for the insertion of a periodontal probe into the furcation area between the roots. Furcation defect is at least 3 mm in depth (and thus, in general, surpassing half of the buccolingual thickness of the tooth) but not through-and-through (i.e. there is still some interradicular bone attached to the angle of the furcation.
15
Class III The level of bone loss allows for "through and through" access of the furcation area. Buccal to lingual on lower molars. Buccal to mesio-palatal and disto-palatal on upper molars. Furcation defect encompassing the entire width of the tooth so that no bone is attached to the angle of the furcation.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start15 Sep 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA FUENMAYOR GARCÉS, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510702
- Sponsor's protocol ID
- H1510580113419
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2018
- Last updated
- 27 Apr 2018
- 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 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Epigenetic Biomarkers (miRNA) in the Gingival Sulcus
- ClinicalTrials.gov ID
- NCT03510702
- Acronym / sponsor ID
- H1510580113419
- Conditions
- Periodontal Diseases, Inflammatory Response
- Keywords
- Epigenetic., microRNA., Periodontitis.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 27 Apr 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.
Epigenetics has produced a high impact in biomedical research and is providing new biomarkers for the diagnosis and prognosis of diseases. In addition, epigenetics is also contributing to analyze the molecular causes underlying diseases, even so periodontal diseases as it has been recently reviewed. In this regard, changes in the methylation of genes codifying for pro-inflammatory and anti-inflammatory cytokines has been previously reported. miRNAs are very promising biomolecules to be used as biomarkers because miRNAs act as signaling molecules and participate in many biological processes, such as cellular development, differentiation, and apoptosis. The high stability of circulating miRNAs in the RNase-rich environment of the bloodstream and also in different biospecimens used in clinical routine, make these biomolecules an optimal source of candidate biomarkers. In fact, miRNAs have demonstrated their value as dynamic biomarkers in a wide variety of human diseases. Therefore, miRNAs can be used for the monitoring of periodontal disease.
The objective of this research is to analyze the levels of bone remodeling RANKL / OPG biomolecular markers, and the epigenetic regulation of these proteins to identify promising biomarkers of periodontal disease.
Material and Methods. Levels of RANKL and OPG will be measured in the gingival crevicular fluid (GCF) to assess the state of bone. These samples will be sent to the lab for quantification by ELISA method.
Furthermore, new epigenetic biomarkers based on the identification of high stable microRNAs will be identified by qRT-PCR in GCF as feasible tools for diagnosis and monitoring of wide range of disease, including periodontal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal patients. | – | Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.Taking gingival Crevicular fluid. |
| Periodontally healthy patients. | – | Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.Taking gingival Crevicular fluid. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients attending to the university who meet the inclusion criteria.
Key inclusion criteria (6 listed)
- Clinical criteria: at least 3 locations in unirradicular teeth with PD 6 mm. 3 samples will be taken from each of these 3 locations (9 total samples). Third molars are not included in the study.
- Patients not treated periodontally.
- 30-60 years.
- 1. Absence of clinical and radiographical periodontal pathology.
Key exclusion criteria (12 listed)
- Group of periodontal patients:
- Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressant...).
- Patients with antibiotic, anti-inflammatory or contraceptive treatment in the previous 3 months or taking antiaggregants in the last 7 days before taking the sample.
- Smokers (> 10 cig/day).
- Pregnant or breast-feeding.
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 |
|---|---|---|
| Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken. Subsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers. | Diagnostic test | Periodontal patients., Periodontally healthy patients. |
Primary outcome
microRNA in gingival crevicular fluid (physiological parameter).
Time frame: 2 years.
Insert the Perio Paper® tip in gingival sulcus until resistance is felt and leave it for 30 seconds.
6 secondary outcomes
Probing depth.
Time frame: 2 years.
Bleeding on probing.
Time frame: 2 years.
Clinical recession.
Time frame: 2 years.
Plaque score of Silness y löe: (1964)
Time frame: 2 years.
Dental movility of Mïller 1950
Time frame: 2 years.
Furcation affection.
Time frame: 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- 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.
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 Diseases and Inflammatory Response, run by University of Valencia at 1 site in Spain.
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 6 inclusion and 12 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 27 Apr 2018. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA in gingival crevicular fluid (physiological parameter). (time frame: 2 years.). 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 27 Apr 2018.