Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:05 AM
Study NCT ID:
NCT04421066
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2020-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Gingival and bone samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria.', 'timeFrame': '1 day', 'description': 'Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate histological characteristics associated with peri-implantitis.'}, {'measure': 'Differences in epigenetic characteristics analyzing DNA methylation in peri-implantitis subjects compared to healthy subjects.', 'timeFrame': '1 day', 'description': 'Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate epigenetic characteristics associated with peri-implantitis.'}], 'secondaryOutcomes': [{'measure': 'Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth.', 'timeFrame': '1 day', 'description': 'To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications.'}, {'measure': 'Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.', 'timeFrame': '1 day', 'description': 'To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.'}, {'measure': 'Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level.', 'timeFrame': '1 day', 'description': 'To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications.'}, {'measure': 'Relation between peri-implant diseases and epigenetic modifications in terms of plaque index.', 'timeFrame': '1 day', 'description': 'To determine whether periodontal measurements plaque index (Sillness \\& Loe index)'}, {'measure': 'Patient-reported outcome measures.', 'timeFrame': '1 day', 'description': 'To determine whether patient-reported outcome measures (PROMs) are related to histological and epigenetic outcomes.\n\nOral Health Impact Profile-14 (OHIP-14) assessed at study visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-Implantitis', 'Peri-implant Mucositis', 'Implant Complication', 'Implant Tissue Failure']}, 'descriptionModule': {'briefSummary': 'In this study genomic, proteomic and histological technologies for the search and characterization of epigenetic modifications and molecular or protein markers, useful in the diagnosis and progression of peri-implant diseases and prevention of implant failure will be used.', 'detailedDescription': 'Samples stored at the Biomedical Research Institute of A Coruña, Xerencia Integrated Management of A Coruña (University Hospital Center of A Coruña), belonging to the collection of the line of research "Oral Health and Systemic Relationship" with registration nº 2017/104 will be used for the realization of the present study.\n\nNucleic acid extraction and histological analysis of the samples will be performed to evaluate the functional epigenetic modifications associated with peri-implant diseases, in an exploratory manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Periodontally Healthy Subjects\n* Peri-implantitis Subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects must have read, understood and signed an informed consent regarding the obtaining of biological samples and participation in the research line of "Oral Health and Systemic Relationship" existing in the Pardiñas Dental Medical Clinic and approved by the ethical committee.\n* The subjects must be between 20-90 years of age.\n* Subjects must be non-smokers or former smokers who have quit smoking for at least one year prior to enrollment in the study.\n\nIn addition to the general criteria listed, samples of a healthy periodontal subject must meet the following criteria when reviewing their medical and dental history :\n\n-Subjects do not have or have had a history of periodontal disease, as described in the " 2017 World Workshop on the Classification of Periodontal and Peri- Implant Diseases and Conditions "\n\nSamples from a subject with peri-implant disease must meet the following criteria:\n\n-Samples of subjects who have at least one implant - supported prosthesis for at least 12 months and affected by peri- implant disease according to the " 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions "\n\nExclusion Criteria:\n\n* Samples of pregnant or lactating women at the time of collection.\n* Samples of subjects who were taking antibiotics within 1 month before collection of the sample.\n* Samples of subjects with chronic use of non-steroidal anti-inflammatory drugs for more than 3 weeks at the time of sample collection. The use of aspirin in low doses (≤81 mg / day) will be allowed .\n* Samples from subjects with disease in the mucosa in the area located around the site of sample collection.\n* Samples of subjects with a systemic disease that would exclude the analysis (for example, severe medical problems, bone metabolism disorders, uncontrolled bleeding disorders, depressed immune system, diseases that require the periodic use of steroids, uncontrolled endocrine disorders) .\n* Samples of subjects with a history of local irradiation therapy in the head / neck area.\n* Samples of subjects with a history of having received treatment with intravenous or subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as bisphosphonates.\n\nSamples of subjects assigned to the healthy group that meet any of the following criteria will be excluded from participation in this study:\n\n* Root fragments, pericoronaritis, endo-perio lesions, dental abscesses at the site of the biopsy.\n* Presence of BOP in the sample collection site.\n\nPeri- implant disease samples / Exclusion of Subjects\n\nThe samples of the subjects assigned to the peri- implant diseases group that meet any of the following criteria will be excluded from participation in this study if the implants were removed due to:\n\n* Inadequate position of the implant.\n* Subjects with implants previously treated surgically for peri- implant disease with antibiotics.'}, 'identificationModule': {'nctId': 'NCT04421066', 'briefTitle': 'Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinica Pardinas'}, 'officialTitle': 'Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants', 'orgStudyIdInfo': {'id': '18-101718'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri-implantitis', 'description': 'Patients with at least one dental implant diagnosed with peri-implantitis undergoing treatment for peri-implantitis as their standard of care will be included in this study.', 'interventionNames': ['Procedure: Gingival and bone sample collection']}, {'label': 'Healthy', 'description': 'Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group.', 'interventionNames': ['Procedure: Healthy individuals']}], 'interventions': [{'name': 'Gingival and bone sample collection', 'type': 'PROCEDURE', 'description': 'Gingival and bone samples will be collected from the sites affected by peri-implantitis during their surgical treatment of peri-implantitis or histological and epigenetic analysis.', 'armGroupLabels': ['Peri-implantitis']}, {'name': 'Healthy individuals', 'type': 'PROCEDURE', 'description': 'Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.', 'armGroupLabels': ['Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15003', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Fundacion Clinica Pardiñas', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}], 'overallOfficials': [{'name': 'Simón Pardiñas López, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación Clínica Pardiñas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simón Pardiñas López', 'class': 'OTHER'}, 'collaborators': [{'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'University Hospital A Coruña', 'class': 'OTHER'}, {'name': 'Instituto de Investigacion Biomedica de A Coruna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Simón Pardiñas López', 'investigatorAffiliation': 'Fundacion Clinica Pardinas'}}}}