Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-24 @ 11:21 PM
Study NCT ID:
NCT03031756
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal Pocket Depth (PPD)', 'timeFrame': '30 day.', 'description': 'PD were evaluated:at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.'}], 'secondaryOutcomes': [{'measure': 'halimeter values.', 'timeFrame': '30 day.', 'description': 'The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Air polishing'], 'conditions': ['Halitosis']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.\n\nSixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '28 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.\n\nExclusion Criteria:\n\n* acute infectious oral lesions,\n* furcation defects,\n* using antibiotics for any reason in the last 4 weeks,\n* periodontal treatment in the last 6 months and\n* pregnant or lactating patients.'}, 'identificationModule': {'nctId': 'NCT03031756', 'briefTitle': 'Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': '33-236-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test', 'description': 'SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation, glycine powder air-polishing (GPAP) was performed for 10 seconds per surface after the instrumentation (Air-Flows Perio Powder, EMS, Nyon, Switzerland) was applied using a Perio-Flows hand-piece connected to an airflow unit (Air-Flow Masters, EMS).', 'interventionNames': ['Device: glycine powder air-polishing (Air-Flows)Perio Powder', 'Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'In the control group, SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation.', 'interventionNames': ['Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)']}], 'interventions': [{'name': 'glycine powder air-polishing (Air-Flows)Perio Powder', 'type': 'DEVICE', 'otherNames': ['EMS, Nyon'], 'armGroupLabels': ['test']}, {'name': 'ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)', 'type': 'DEVICE', 'otherNames': ['EMS Piezon Master'], 'armGroupLabels': ['control', 'test']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hasan Guney YILMAZ, DDS,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Near East University, Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof Dr', 'investigatorFullName': 'Hasan Guney YILMAZ', 'investigatorAffiliation': 'Near East University, Turkey'}}}}