Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 9:43 AM
Study NCT ID:
NCT06033859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-10
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
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': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D008283', 'term': 'Maintenance'}], 'ancestors': [{'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Peri-implant mucosal phenotype', 'timeFrame': 'Baseline and 15 months', 'description': 'Assessed by determining the keratinized mucosa (KM) width, measured in millimeters with a periodontal probe, at the mid-buccal aspect of the implant from the gingival margin to the mucogingival junction and the mucosal thickness, measured in millimeters, at the mid-buccal aspect of the implant, 1.5mm below the gingival margin with an endodontic spreader (0.25mm diameter) and endodontic cursor.'}], 'primaryOutcomes': [{'measure': 'Marginal Bone Loss (MBL)', 'timeFrame': 'Baseline and 15 months', 'description': 'MBL will be calculated by measuring the difference in marginal bone level between the standardized periapical radiographs. Progression will have to exceed a threshold of 0.5mm to be considered.'}], 'secondaryOutcomes': [{'measure': 'Incidence of BOP', 'timeFrame': '3, 6, 9, 12 and 15 months', 'description': 'Changes in BOP at each of the 4 sites assessed in baseline, according to Mombelli et al. (1987):\n\n1. Score 0 - No BOP\n2. Score 1 - Bleeding dot\n3. Score 2 - Continuous line of blood that fills the sulcus\n4. Score 3 - Profuse bleeding and/or hemorrhage drip.'}, {'measure': 'Changes in probing depth (PD)', 'timeFrame': 'Baseline, 3, 6, 9, 12 and 15 months', 'description': 'Differences in probing depth over the study period. PD increase must exceed a threshold of 0.8mm to be considered progression.'}, {'measure': 'Mucosal recession', 'timeFrame': 'Baseline, 3, 6, 9, 12 and 15 months', 'description': 'Measured at each of the 4 locations surrounding the implant of interest.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bleeding on probing', 'Peri-implant mucositis'], 'conditions': ['Peri-Implantitis', 'Bleeding of Subgingival Space']}, 'descriptionModule': {'briefSummary': 'The primary goal of the present prospective cohort study is to evaluate the effect of varying incidences of BOP at implant sites across 15 months of maintenance visits on the probability of peri-implant disease progression. Over 15 months, participants will attend 6 visits where clinical measurements and maintenance care will be performed every 3 months.', 'detailedDescription': 'Screening/Baseline/Maintenance Visit 1 (V1) After participants have consented, their health history will be reviewed, and their vitals including blood pressure and heart rate will be recorded. A dental exam of the teeth and gums will be completed. During this exam, a UNC 15 periodontal probe will be used to perform the clinical assessments. Intraoral photographs will be taken. An x-ray of the implant(s) included in the study will be taken using a customized x-ray holder (created during Visit 1) so that at the end of the study, a final x-ray will be taken in the exact same position. Finally, each participant will receive a dental prophylaxis (D1110) or maintenance (D4910) according to their prior periodontal diagnosis.\n\nMaintenance Visits 2-6 (V2-V6) Participants will return in 3-month intervals at approximately 3, 6, 9, 12, and 15 months (+/- 10 days) for Study Visits V2 - V6. At each of these visits, individuals will be asked about continued participation in the study. Participants will also be asked if there have been any changes to medical or dental history and if they are taking any new medications. Intraoral photographs of the study area will be performed, as well as, collecting measurements from around the dental implant(s), and providing regular dental cleaning. At the 15 month visit, a final x-ray will be taken using the custom x-ray holder made at the first visit.\n\nClinical and radiographic assessments will include:\n\n1. BOP: at each of the 4 measured locations surrounding the implant of interest will be recorded as follows:\n\n 1. Score 0 - No BOP\n 2. Score 1 - Bleeding dot\n 3. Score 2 - Continuous line of blood that fills the sulcus\n 4. Score 3 - Profuse bleeding and/or hemorrhage drip.\n2. Probing depths (PD): at 4 locations surrounding the implant of interest (mesiolingual (ML), mesiobuccal (MB), distolingual (DL), and distobuccal (DB)). PD increase must exceed a threshold of 0.8mm to be considered progression.\n3. Recession: measured at each of the 4 locations surrounding the implant of interest.\n4. Keratinized mucosa width: measured at the midbuccal aspect of the implant(s).\n5. Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the mucosal margin, at the midbuccal aspect of the implant(s).\n6. Marginal bone loss (MBL): measured by overlaying the baseline and final radiographs and measuring the change in marginal bone levels. Progression will have to exceed a threshold of 0.5mm to be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population from which cases will be recruited are from the patients of record at the University of Pittsburgh Periodontics Department who meet the inclusion criteria of the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be enrolled in the study, the participant must meet the following inclusion criteria:\n\n* adults in good general health (at least ASA 2)\n* having ≥ 1 dental implant that was restored before January 2021\n* patients of the University of Pittsburgh Periodontics Department\n* available for maintenance visits every 3 months for the length of the study\n\nExclusion Criteria:\n\n* Active infectious diseases of any kind\n* Pregnant or planning to become pregnant (self-reported)\n* Congenital or metabolic bone disorders\n* Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset\n* Co-morbid conditions that would affect the study outcome or interpretation of study results\n* Require treatment for periodontal disease prior to baseline'}, 'identificationModule': {'nctId': 'NCT06033859', 'acronym': 'BOP', 'briefTitle': 'Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study', 'orgStudyIdInfo': {'id': 'STUDY22060166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implants with BOP score 0', 'description': 'Implants with no BOP according to the modified bleeding index at baseline.', 'interventionNames': ['Diagnostic Test: Clinical measurements', 'Diagnostic Test: Radiographic measurement', 'Procedure: Dental prophylaxis or maintenance']}, {'label': 'Implants with BOP score 1', 'description': 'Implants with a bleeding dot at baseline.', 'interventionNames': ['Diagnostic Test: Clinical measurements', 'Diagnostic Test: Radiographic measurement', 'Procedure: Dental prophylaxis or maintenance']}, {'label': 'Implants with BOP score 2', 'description': 'Implants with a continuous line of blood that fills the sulcus at baseline.', 'interventionNames': ['Diagnostic Test: Clinical measurements', 'Diagnostic Test: Radiographic measurement', 'Procedure: Dental prophylaxis or maintenance']}, {'label': 'Implants with BOP score 3', 'description': 'Implants with a profuse bleeding and/or hemorrhage drip at baseline.', 'interventionNames': ['Diagnostic Test: Clinical measurements', 'Diagnostic Test: Radiographic measurement', 'Procedure: Dental prophylaxis or maintenance']}], 'interventions': [{'name': 'Clinical measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'With the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed.', 'armGroupLabels': ['Implants with BOP score 0', 'Implants with BOP score 1', 'Implants with BOP score 2', 'Implants with BOP score 3']}, {'name': 'Radiographic measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'A standardized periapical radiograph of the implant will be completed at the beginning and the end of study to determine the marginal bone loss.', 'armGroupLabels': ['Implants with BOP score 0', 'Implants with BOP score 1', 'Implants with BOP score 2', 'Implants with BOP score 3']}, {'name': 'Dental prophylaxis or maintenance', 'type': 'PROCEDURE', 'description': 'Dental prophylaxis or maintenance will be performed every 3 months.', 'armGroupLabels': ['Implants with BOP score 0', 'Implants with BOP score 1', 'Implants with BOP score 2', 'Implants with BOP score 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh School of Dental Medicine', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Andrea Ravida, DDS MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrea Ravida', 'investigatorAffiliation': 'University of Pittsburgh'}}}}