Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-04-15 @ 2:17 AM
Study NCT ID:
NCT02091258
Status:
UNKNOWN
Last Update Posted:
2017-09-27
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tooth Loss in Periodontitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tooth loss', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'Tooth loss in periodontitis patients is associated with patient and site factors as well as with treatment provided. Not much is known about long-term tooth loss in periodontitis patients in private practice in the UK. The study plans to follow-up 200 subjects with periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment provided, site and patient risk factors on tooth loss will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '200 patients with periodontitis on maintenance therapy (after initial/ corrective periodontal therapy) will be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n1. Initial diagnosis of chronic or aggressive periodontitis (Lindhe et al. 1999, Lang et al. 1999), with at least two sites with PPD and CAL ≥5mm\n2. Diagnosed and treated by the same periodontist (LN)\n3. Willing to give written informed consent for study participation\n4. Willing to undergo SPT as per standard of care for at least 5 years\n\nEXCLUSION CRITERIA:\n\n1. Serious medical history that prevents patients from undergoing dental treatment\n2. History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures\n3. Current alcohol or drug abuse\n4. Self-reported pregnancy or lactation\n5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may compromise trial participation and/or interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial'}, 'identificationModule': {'nctId': 'NCT02091258', 'briefTitle': 'Tooth Loss in Periodontitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Tooth Loss in Periodontitis Patients on Long-term Maintenance in Private Practice', 'orgStudyIdInfo': {'id': 'UCL 14/0110'}}, 'contactsLocationsModule': {'locations': [{'zip': 'CM23 3AZ', 'city': "Bishop's Stortford", 'state': 'Herts', 'country': 'United Kingdom', 'facility': 'The Dentist', 'geoPoint': {'lat': 51.87113, 'lon': 0.15868}}, {'zip': 'W60SL', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Ravenscourt Dental Practice', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Luigi Nibali, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}