Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 9:23 AM
Study NCT ID:
NCT03444350
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2018-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the Ozone in Periodontal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The clinician who performed the therapy (S.D.) was not informed about the modality of the treatment till the first session of each patient (right at this moment, a sealed envelope was opened and the clinician was then able to see the treatment modality). The results of the study were evaluated in a blinded manner (both before treatment and after treatment).\n\nThe ozone was applied in the gingival sulcus of all teeth with a fine-tipped tool placed in the periodontal pocket. It was moved in the apical-coronal direction in a sweeping motion. Within 30 seconds, this application was applied in mesial, distal, buccal, and lingual manner. No ozone application was used in the Control Group, and they received only placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RANDOMIZED CONTROLLED TRIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory findings', 'timeFrame': 'One month', 'description': 'The total antioxidant status levels ( mmol/L) were determined in the saliva samples.'}], 'secondaryOutcomes': [{'measure': 'Clinical findings', 'timeFrame': 'One month', 'description': 'Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Periodontal treatment', 'Ozone', 'oxidative stress'], 'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '30673028', 'type': 'DERIVED', 'citation': 'Seydanur Dengizek E, Serkan D, Abubekir E, Aysun Bay K, Onder O, Arife C. Evaluating clinical and laboratory effects of ozone in non-surgical periodontal treatment: a randomized controlled trial. J Appl Oral Sci. 2019 Jan 14;27:e20180108. doi: 10.1590/1678-7757-2018-0108.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in addition to scaling and root planning.\n\nThe study population consisted of 40 patients with CP (chronic periodontitis). It was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \\[1 W (100 mJ, 10 Hz)\\] was applied to the Test Group. The Control Group, on the other hand, had only SRP.The clinical periodontal parameters were performed and saliva samples were taken before SRP (baseline) and 1 month after treatment. The periodontal examination involved assessing the plaque index, gingival index , probing depth, and clinical attachment level. The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.', 'detailedDescription': 'The study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. The duration of the study was 1 month.\n\nThe study was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \\[1 W (100 mJ, 10 Hz), (n=20)\\] was applied to the Test Group.\n\nThe Control Group, on the other hand, had SRP plus placebo (n=20). The patients were distributed in random order to the 2 groups (each group had 20 patients). One patient in the Ozone Group and 2 patients in the Control Group left the study.\n\nThe following clinical periodontal parameters were performed immediately before SRP (baseline), and 1 month after treatment for each test and control groups. Plaque index, GI, PD and CAL were recorded. All clinical parameter measurements were used a manual periodontal probe (PCP- 12, Hu-Friedy, Chicago, IL, USA).\n\nThe total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients having had generalize CP which were agreed upon by consensus at the World Workshop in Periodontics in 1999 \\[24\\];\n2. three or more teeth having at least two quadrants with probing depth between 4 and 6 mm and radiographic signs of bone loss;\n3. aged 30 years and above;\n4. a minimum of 20 teeth.\n\nExclusion Criteria:\n\n1. received periodontal therapy within the last 12 months;\n2. systemic diseases which could affect periodontal treatment outcomes;\n3. having taken systemic antibiotics within the last 6 months;\n4. pregnancy or breast-feeding for female patients.'}, 'identificationModule': {'nctId': 'NCT03444350', 'briefTitle': 'Use of the Ozone in Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Çanakkale Onsekiz Mart University'}, 'officialTitle': 'Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Inonu University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'SRP plus placebo', 'interventionNames': ['Device: SRP plus placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gaseous ozone group', 'description': 'SRP plus gaseous ozone \\[1 W (100 mJ, 10 Hz)\\]', 'interventionNames': ['Device: Gaseous ozone']}], 'interventions': [{'name': 'Gaseous ozone', 'type': 'DEVICE', 'otherNames': ['Ozone DTA'], 'description': 'SRP plus gaseous ozone', 'armGroupLabels': ['Gaseous ozone group']}, {'name': 'SRP plus placebo', 'type': 'DEVICE', 'description': 'only SRP', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Abubekir Eltas, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. The duration of the study was 1 month. Inonu University Ethics Committee approved the study protocol in accordance with the Helsinki Declaration. Informed Consent Form were received from the participants with their signatures. The participating patients were selected from Inonu University, Department of Periodontology Patient Pool. 40 patients constituted the Study Group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Çanakkale Onsekiz Mart University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inonu University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Abubekir Eltas', 'investigatorAffiliation': 'Çanakkale Onsekiz Mart University'}}}}