Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 8:58 AM
Study NCT ID:
NCT03525457
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to Periodontal Therapy in a Chronic Kidney Disease Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Clinical Attachment Level (CAL)', 'timeFrame': '3 months', 'description': 'Change from baseline CAL (in mm) at three months'}], 'secondaryOutcomes': [{'measure': 'Change in Bleeding on probing (BOP)', 'timeFrame': '3 months', 'description': 'Change from baseline BOP (%) at three months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glomerular filtration rate', 'Periodontitis', 'Chronic kidney disease'], 'conditions': ['Chronic Kidney Disease Stage 5', 'Periodontal Disease']}, 'referencesModule': {'references': [{'pmid': '27135778', 'type': 'BACKGROUND', 'citation': 'Almeida S, Figueredo CM, Lemos C, Bregman R, Fischer RG. Periodontal treatment in patients with chronic kidney disease: a pilot study. J Periodontal Res. 2017 Apr;52(2):262-267. doi: 10.1111/jre.12390. Epub 2016 May 2.'}, {'pmid': '20500539', 'type': 'BACKGROUND', 'citation': 'Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.'}, {'pmid': '23432795', 'type': 'BACKGROUND', 'citation': 'Chambrone L, Foz AM, Guglielmetti MR, Pannuti CM, Artese HP, Feres M, Romito GA. Periodontitis and chronic kidney disease: a systematic review of the association of diseases and the effect of periodontal treatment on estimated glomerular filtration rate. J Clin Periodontol. 2013 May;40(5):443-56. doi: 10.1111/jcpe.12067. Epub 2013 Feb 21.'}, {'pmid': '27038430', 'type': 'BACKGROUND', 'citation': 'Limeres J, Garcez JF, Marinho JS, Loureiro A, Diniz M, Diz P. Early tooth loss in end-stage renal disease patients on haemodialysis. Oral Dis. 2016 Sep;22(6):530-5. doi: 10.1111/odi.12486. Epub 2016 May 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate periodontal and systemic parameters of a cohort of chronic kidney disease (stage 5) patients, before and three months after non-surgical periodontal treatment. It does not consider a control group.', 'detailedDescription': 'Dental biofilm is a source of inflammation and infection of periodontal tissues. In the last 20 years the interaction between periodontal infections and systemic conditions has been largely studied, suggesting that the inflammation caused in the periodontal tissues could cause a response in other parts of the body.\n\nRecent studies suggest that there could be an association between periodontal disease and chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic kidney disease patients in Stage 5 (candidates to renal transplant)\n\nExclusion Criteria:\n\n* Younger than 18 year old.'}, 'identificationModule': {'nctId': 'NCT03525457', 'briefTitle': 'Response to Periodontal Therapy in a Chronic Kidney Disease Population', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant', 'orgStudyIdInfo': {'id': '180104004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Non surgical periodontal therapy', 'interventionNames': ['Procedure: Non Surgical Periodontal Therapy']}], 'interventions': [{'name': 'Non Surgical Periodontal Therapy', 'type': 'PROCEDURE', 'description': 'Non Surgical Periodontal Therapy in 2 to 3 sessions', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Maite C Souyet, MsC', 'role': 'CONTACT', 'email': 'msouyet@gmail.com', 'phone': '+56878786186'}], 'facility': 'Clínica Odontológica Docente UC', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Maite C Souyet, MsC', 'role': 'CONTACT', 'email': 'msouyet@gmail.com', 'phone': '+56978786186'}, {'name': 'Patricio F Smith, PhD', 'role': 'CONTACT', 'email': 'psmithf@uc.cl'}], 'overallOfficials': [{'name': 'Maite C Souyet, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Catolica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, MsC', 'investigatorFullName': 'Maité Souyet', 'investigatorAffiliation': 'Pontificia Universidad Catolica de Chile'}}}}