Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT04177732
Status:
UNKNOWN
Last Update Posted:
2019-12-02
First Post:
2019-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calprotectin concentration in GCF', 'timeFrame': '3 weeks', 'description': 'One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation'}, {'measure': 'Cross-linked N-telopeptides concentration in GCF', 'timeFrame': '3 weeks', 'description': 'One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarkers', 'Calprotectin', 'Cross-linked N-telopeptides'], 'conditions': ['Peri-Implantitis', 'Dental Implant Failed']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the efficacy of Calprotectin and cross-linked N-telopeptides of type I collagen levels in crevicular fluid as a biomarker in patients with peri-implantitis.', 'detailedDescription': 'Ethical approval will be obtained from the ethical committee of the Riyadh Elm University and written consent will be obtained from all the patients after explaining in detail the entire research protocol.\n\nInclusion criteria for the present study:\n\n* 10 patients who underwent dental implant procedure five to ten years ago; among these- 5 patients will be with healthy peri-implant status and 5 patients with presence of peri-implant diseases\n* Patients of comparable age and gender distribution- Patients within the age group of 25 to 45 years; and 3 males and 2 females in peri-implant diseases group and 3 males and 2 females in healthy peri-implant status group\n* Patients with negative history of any systemic illness, metabolic disease.\n* Patients with negative history of antibiotic therapy in past ninety days.\n\nAfter collecting the PICF and GCF, examination of probing depth (PD), bleeding on probing (BOP) and gingival index (GI) will be done.Modified Löe and Silness criteria will be used for evaluating the GI score.Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment. Periodontal sites with PD of equal to or more than 3mm with GI score of equal to or more than 1mm and presence or absence of BOP, will be categorized as peri-implant disease sites. Periodontal sites with PD of less than 3mm with GI score of 0 and absence of BOP will be categorized as healthy implant sites. Sterile paper strips will be used for collecting PICF samples, followed by PICF sample preparation using modified criteria described previously in the literature. Isolation of the PICF sampling sites will be done using cotton roles. This will be followed by removal of supra-gingival plaques and gentle air drying. Insertion of the periopaper will be done into the peri-implant crevice and will be kept there for thirty seconds. Periotron will be used for measuring the volume of PICF. Further, all the samples will be sent to laboratory where ELISA technique will be used for measuring the calprotectin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nExclusion Criteria:\n\n* Patients with history of any systemic illness, metabolic disease.\n* Patients with history of antibiotic therapy in past ninety days.'}, 'identificationModule': {'nctId': 'NCT04177732', 'briefTitle': 'Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Elm University'}, 'officialTitle': 'Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides of Type I Collagen Levels in Crevicular Fluid as a Biomarker in Patients With Peri-implantitis: A Clinical Study', 'orgStudyIdInfo': {'id': 'Calprotectin-N-telopeptides'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy peri-implant status', 'description': 'Patient with healthy peri-implant status', 'interventionNames': ['Diagnostic Test: Collection of sulcular (crevicular) fluid', 'Diagnostic Test: Probing depth', 'Diagnostic Test: Bleeding on probing', 'Diagnostic Test: Gingival index', 'Diagnostic Test: Bone loss rate of alveolar bone']}, {'type': 'OTHER', 'label': 'Presence of peri-implant diseases', 'description': 'Patients with presence of peri-implant diseases', 'interventionNames': ['Diagnostic Test: Collection of sulcular (crevicular) fluid', 'Diagnostic Test: Probing depth', 'Diagnostic Test: Bleeding on probing', 'Diagnostic Test: Gingival index', 'Diagnostic Test: Bone loss rate of alveolar bone']}], 'interventions': [{'name': 'Collection of sulcular (crevicular) fluid', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sterile paper strips will be used for collecting crevicular fluid', 'armGroupLabels': ['Healthy peri-implant status', 'Presence of peri-implant diseases']}, {'name': 'Probing depth', 'type': 'DIAGNOSTIC_TEST', 'description': 'Williams SE manual probe will be used to measure the probing depth', 'armGroupLabels': ['Healthy peri-implant status', 'Presence of peri-implant diseases']}, {'name': 'Bleeding on probing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction', 'armGroupLabels': ['Healthy peri-implant status', 'Presence of peri-implant diseases']}, {'name': 'Gingival index', 'type': 'DIAGNOSTIC_TEST', 'description': 'Modified Löe and Silness criteria will be used for evaluating the gingival index score', 'armGroupLabels': ['Healthy peri-implant status', 'Presence of peri-implant diseases']}, {'name': 'Bone loss rate of alveolar bone', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment', 'armGroupLabels': ['Healthy peri-implant status', 'Presence of peri-implant diseases']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansour Assery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant in Prosthodontics & Dental Implant', 'investigatorFullName': 'Mansour Assery', 'investigatorAffiliation': 'Riyadh Elm University'}}}}