Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03510702
Status:
UNKNOWN
Last Update Posted:
2018-04-27
First Post:
2018-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Taking crevicular gingival fluid samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2018-04-01', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microRNA in gingival crevicular fluid (physiological parameter).', 'timeFrame': '2 years.', 'description': 'Insert the Perio Paper® tip in gingival sulcus until resistance is felt and leave it for 30 seconds.'}], 'secondaryOutcomes': [{'measure': 'Probing depth.', 'timeFrame': '2 years.', 'description': '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.'}, {'measure': 'Bleeding on probing.', 'timeFrame': '2 years.', 'description': '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).'}, {'measure': 'Clinical recession.', 'timeFrame': '2 years.', 'description': 'Clinical recession will be measured in the same six sites as before between the Amelocemental junction and the gingival margin.'}, {'measure': 'Plaque score of Silness y löe: (1964)', 'timeFrame': '2 years.', 'description': 'The Plaque will be scored as follows:\n\nScore 0 = No plaque\n\nScore 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.\n\nScore 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.\n\nScore 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.\n\nThe 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)'}, {'measure': 'Dental movility of Mïller 1950', 'timeFrame': '2 years.', 'description': 'Class I\n\nUp to 1 mm of movement in a horizontal direction.\n\nClass II Greater than 1 mm of movement in a horizontal direction. Class III\n\nExcessive horizontal movement and vertical movement.'}, {'measure': 'Furcation affection.', 'timeFrame': '2 years.', 'description': 'Class I:\n\nThe 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.\n\nClass 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.\n\n15\n\nClass 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epigenetic.', 'microRNA.', 'Periodontitis.'], 'conditions': ['Periodontal Diseases', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nMaterial 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.\n\nFurthermore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending to the university who meet the inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup of periodontal patients:\n\n1. 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.\n2. Patients not treated periodontally.\n3. 30-60 years.\n\nPeriodontally healthy group:\n\n1\\. Absence of clinical and radiographical periodontal pathology.\n\nExclusion Criteria:\n\n* Group of periodontal patients:\n\n 1. Aggressive Periodontal Disease (Armitage, 1999).\n 2. Patients with controlled periodontal disease with plaque and gingival indexes ≤20%.\n 3. Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressants, etc ...).\n 4. 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.\n 5. Smokers (\\> 10 cig. /day).\n 6. Pregnant or breast-feeding.\n\nPeriodontally healthy group:\n\n1. Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressant...).\n2. 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.\n3. Smokers (\\> 10 cig/day).\n4. Pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT03510702', 'briefTitle': 'SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Screening of Epigenetic Biomarkers (miRNA) in the Gingival Sulcus', 'orgStudyIdInfo': {'id': 'H1510580113419'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontal patients.', 'description': 'Taking gingival Crevicular fluid.', 'interventionNames': ['Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.']}, {'label': 'Periodontally healthy patients.', 'description': 'Taking gingival Crevicular fluid.', 'interventionNames': ['Diagnostic Test: Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.']}], 'interventions': [{'name': 'Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken.\n\nSubsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers.', 'armGroupLabels': ['Periodontal patients.', 'Periodontally healthy patients.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Fuenmayor Garcés, Postgraduate student', 'role': 'CONTACT', 'email': 'anafuenmayorgarces@gmail.com', 'phone': '0034680964117'}], 'facility': 'Ana Fuenmayor Garcés', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate student.', 'investigatorFullName': 'ANA FUENMAYOR GARCÉS', 'investigatorAffiliation': 'University of Valencia'}}}}