Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-30 @ 1:38 AM
Study NCT ID:
NCT04283903
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-implant diseases presence', 'timeFrame': 'Baseline (cross-sectional part)', 'description': 'Presence or absence of peri-implant mucositis or peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018)'}, {'measure': 'Disease resolution of peri-implantitis', 'timeFrame': '1-year after treatment (longitudinal part)', 'description': 'According to the criteria proposed by Sanz \\& Chapple (2012)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-implant Mucositis', 'Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'Due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. In fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress.\n\nThis project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (PICF) with an integrated approach from implants with peri-implant diseases.\n\nTwenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. For each of the selected participants, the PICF from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. One year after the corresponding treatment is provided, the PICF of the treated implants with peri-implantitis will be sampled again.\n\nBoth proteomic and metabolomic profiling of the samples will be carried out. The most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'According to a study with a similar design on periodontitis (Barnes et al. 2009), twenty-five patients with at least one implant with peri-implantitis and one implant with peri-implant mucositis (Berglundh et al. 2018) will be selected in Complutense University of Madrid for PICF collection, before any treatment is provided. This will be done with the aim of excluding potential inter-individual variability in the metabolomic and proteomic profile of PICF.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one implant with peri-implant mucositis and one with peri-implantitis\n\nExclusion Criteria:\n\n* Previously treated implants to be included'}, 'identificationModule': {'nctId': 'NCT04283903', 'briefTitle': 'Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases', 'orgStudyIdInfo': {'id': 'Metabol_Proteom_Implants'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PICF', 'type': 'DIAGNOSTIC_TEST', 'description': 'PICF collection from 4 sites'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariano Sanz Alonso', 'role': 'CONTACT'}, {'name': 'Mario Romandini', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mariano Sanz Alonso', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Periodontology, University Complutense Madrid, Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Mario Romandini', 'role': 'CONTACT', 'email': 'maromand@ucm.es', 'phone': '+393801563046'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}