Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-01 @ 8:40 AM
Study NCT ID:
NCT03365167
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of periodontal pocket depth', 'timeFrame': '0,1,2,3,4,5,6 months', 'description': 'depth of periodontal pocket of each tooth'}], 'secondaryOutcomes': [{'measure': 'change of Bleeding on Probing', 'timeFrame': '0,1,2,3,4,5,6 month', 'description': 'sign of bleeding after 1 minutes post probing the tooth pocket'}, {'measure': 'change of Full Mouth Bleeding Score', 'timeFrame': '0,1,2,3,4,5,6 month', 'description': 'Bleeding Score of all teeth that is calculated by counting the Four dental levels that have sign of bleeding post probing (including , mesio-buccal,mid- buccal, disto-buccal and lingual) divided by the total number of total teeth in the mouth \\*4'}, {'measure': 'change of Clinical attachment loss', 'timeFrame': '0,1,2,3,4,5,6 month', 'description': 'distance from depth of tooth sulcus to cemento-enamel junction'}, {'measure': 'change of Full Mouth Plaque Score', 'timeFrame': '0,1,2,3,4,5,6 month', 'description': 'the number of 4 surfaces of each tooth(mesiobuccal, mid buccal, disto buccal and lingual surfaces) that have plaque that is disclosed by disclosing tables , then counting the number of the colored surface of all teeth divided by the total number of total teeth in the mouth\\*4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LANAP', 'Periodontitis'], 'conditions': ['Periodontitis', 'Laser']}, 'referencesModule': {'references': [{'pmid': '34411291', 'type': 'DERIVED', 'citation': 'Dortaj D, Bassir SH, Hakimiha N, Hong H, Aslroosta H, Fekrazad R, Moslemi N. Efficacy of Nd:YAG laser-assisted periodontal therapy for the management of periodontitis: A double-blind split-mouth randomized controlled clinical trial. J Periodontol. 2022 May;93(5):662-672. doi: 10.1002/JPER.21-0242. Epub 2021 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth', 'detailedDescription': 'this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side\n\nExclusion Criteria:\n\n* pregnant smoker systemic disease breast feeding'}, 'identificationModule': {'nctId': 'NCT03365167', 'briefTitle': 'Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Clinical Evaluation of the Effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis( Randomized Clinical Trial Study)', 'orgStudyIdInfo': {'id': '96-02-97-36092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LANAP', 'description': 'LANAP (Laser Assisted New Attachment Procedure)', 'interventionNames': ['Radiation: LANAP (Laser Assisted New Attachment Procedure)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LANAP off', 'description': 'laser therapy in off mode', 'interventionNames': ['Radiation: LANAP off']}], 'interventions': [{'name': 'LANAP (Laser Assisted New Attachment Procedure)', 'type': 'RADIATION', 'description': 'radiation of Nd:YAG laser in periodontal pocket', 'armGroupLabels': ['LANAP']}, {'name': 'LANAP off', 'type': 'RADIATION', 'description': 'radiation of Nd:YAG laser in off mode in periodontal pocket', 'armGroupLabels': ['LANAP off']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Neda Moslemi', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Neda Moslemi', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}