Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06726902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-12
First Post:
2024-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding on probing', 'timeFrame': 'up to six months'}, {'measure': 'Pain Assessment', 'timeFrame': 'up to six months', 'description': 'Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)'}, {'measure': 'Probing depth', 'timeFrame': 'up to six months'}, {'measure': 'Plaque accumulation', 'timeFrame': 'up to six months'}, {'measure': 'Clinical attachment level', 'timeFrame': 'up to six months'}, {'measure': 'Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)', 'timeFrame': 'one month'}, {'measure': 'Microbiological Assessment of Porphyromonas gingivalis (Pg)', 'timeFrame': 'one month'}, {'measure': 'Microbiological Assessment of Tannerella forsythia (Tf)', 'timeFrame': 'one month'}, {'measure': 'Microbiological Assessment of Treponema denticola (Td)', 'timeFrame': 'one month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GBT', 'Periodontitis', 'SI'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,\n2. Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI\n3. Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.\n4. No history of systemic disease that may influence periodontal disease\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding,\n2. Smokers with more than seven cigarettes per day\n3. Patients that had a treatment with antibiotics within six months before the study\n4. Need for periodontal surgery or adjunctive antibiotic treatment to the SI\n5. Patients who had any periodontal treatment during the last year before the study.\n6. Patients with known systemic or autoimmune disease.'}, 'identificationModule': {'nctId': 'NCT06726902', 'acronym': 'GBT', 'briefTitle': 'Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'IORG 0008839-0854-01/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group I (GBT and SI + erythritol powder)', 'description': 'will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder', 'interventionNames': ['Device: GBT and SI with erythritol powder']}, {'type': 'EXPERIMENTAL', 'label': 'Test Group II (GBT and SI + glycine powder)', 'description': 'will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder', 'interventionNames': ['Other: GBT and SI with glycine powder']}, {'type': 'EXPERIMENTAL', 'label': 'Test Group III (GBT and SI + Trehalose powder)', 'description': 'will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder', 'interventionNames': ['Other: GBT and SI with trehalose powder']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group VI (SRP and SI)', 'description': 'will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder', 'interventionNames': ['Other: SRP and SI']}], 'interventions': [{'name': 'GBT and SI with erythritol powder', 'type': 'DEVICE', 'otherNames': ['guided biofilm therapy'], 'description': 'Non-Surgical Periodontal treatment:\n\n1. Guided Biofilm Therapy\n\n * Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system.\n * Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with erythritol powder .\n2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only.', 'armGroupLabels': ['Test Group I (GBT and SI + erythritol powder)']}, {'name': 'GBT and SI with glycine powder', 'type': 'OTHER', 'description': 'Non-Surgical Periodontal treatment:\n\n1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with glycine powder.\n2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only', 'armGroupLabels': ['Test Group II (GBT and SI + glycine powder)']}, {'name': 'GBT and SI with trehalose powder', 'type': 'OTHER', 'description': 'Non-Surgical Periodontal treatment:\n\n1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with trehalose powder .\n2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only', 'armGroupLabels': ['Test Group III (GBT and SI + Trehalose powder)']}, {'name': 'SRP and SI', 'type': 'OTHER', 'description': 'conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed', 'armGroupLabels': ['Control Group VI (SRP and SI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21923', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Rania Abdelaziz Fahmy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'six month', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diana Ibrahim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Periodontology MSc. Candidate', 'investigatorFullName': 'Diana Ibrahim', 'investigatorAffiliation': 'Alexandria University'}}}}