Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-01 @ 8:59 PM
Study NCT ID:
NCT06319261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal pocket depth (PPD)', 'timeFrame': '3 months', 'description': 'PPD will be measured from the gingival margin to the base of the pocket by using the University of North Carolina 15 probe (UNC15) probe to measure the reduction of the pocket depth in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': '3 months', 'description': 'Biofilm will be determined using a dichotomous scoring system as present (1) or absent (0) after using a disclosing agent to assess the agreement on the scoring of the biofilm.'}, {'measure': 'Bleeding on probing', 'timeFrame': '3 months', 'description': 'Bleeding on probing will be recorded as present (1) or absent (0) after probing all the sites by using UNC15 probe.'}, {'measure': 'Relative attachment level', 'timeFrame': '3 months', 'description': 'Relative attachment level will be recorded by making a customized acrylic stent and then measuring the relative attachment level from a fixed point on the stent to the base of the pocket by using UNC15 probe in millimeters.'}, {'measure': 'Changes in the bacterial load', 'timeFrame': '3 months', 'description': "Real time polymerase chain reaction (qPCR) will be used to assess the detection and the quantity of these periodontal pathogens (P.gingivalis, Aggregatibacter actinomycetemcomitans and filifacter alocis) in the subgingival biofilm sample according to the manufacturer's instructions. identification of target bacteria through PCR will be executed using species specific primers."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.\n\nthe objectives are\n\n1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.\n\nthe hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.\n\nThe participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.\n\nFor each patient, each site will be randomly assigned to either treatment protocol:\n\n1. Sites treated with GBT.\n2. Sites treated with conventional manual instrumentation only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients, aged more than 18 years.\n2. No history of any systemic diseases.\n3. Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease.\n4. The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.\n\nExclusion Criteria:\n\n1. Smokers.\n2. Pregnant and lactating mothers.\n3. History of any previous subgingival instrumentation in the last 3 months.\n4. The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months.\n5. Regular use of medication to control systemic illness.\n6. The presence of perio-endo lesion.'}, 'identificationModule': {'nctId': 'NCT06319261', 'briefTitle': 'Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '858623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'guided biofilm therapy group', 'description': 'Sites treated with guided biofilm therapy.', 'interventionNames': ['Procedure: guided biofilm therapy']}, {'type': 'OTHER', 'label': 'conventional root debridement group', 'description': 'Sites treated with conventional manual instrumentation only.', 'interventionNames': ['Procedure: root surface debridement']}], 'interventions': [{'name': 'guided biofilm therapy', 'type': 'PROCEDURE', 'description': 'Removing plaque and calculus by initially detecting it with a disclosing agent followed by the use of air abrasive powder for the removal of supra and subgingival plaque.', 'armGroupLabels': ['guided biofilm therapy group']}, {'name': 'root surface debridement', 'type': 'PROCEDURE', 'description': 'Removing plaque and calculus by conventional root surface debridement', 'armGroupLabels': ['conventional root debridement group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reem Hussain, B.D.S', 'role': 'CONTACT', 'email': 'reem.hussein2205@codental.uobaghdad.edu.iq', 'phone': '07702618155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dentist', 'investigatorFullName': 'Reem Hussain Faisal', 'investigatorAffiliation': 'University of Baghdad'}}}}