Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT03410602
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nonsurgical Periodontal Therapy on Banded First Molars
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012534', 'term': 'Dental Scaling'}], 'ancestors': [{'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month', 'timeFrame': 'Baseline to 12th month', 'description': 'Radiographic evidence of alveolar crestal bone level was measured around each banded first molar'}], 'secondaryOutcomes': [{'measure': 'Change from baseline plaque index at 12th month', 'timeFrame': 'Baseline to 12 month', 'description': 'Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).'}, {'measure': 'Change from baseline gingival index at 12th month', 'timeFrame': 'Baseline to 12th month', 'description': 'The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).'}, {'measure': 'Change from baseline probing pocket depth at 12th month', 'timeFrame': 'Baseline to 12th month', 'description': 'The probing pocket depth was measured clinically using Williams periodontal probe at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, distolingual and lingual) of each banded first molar.'}, {'measure': 'Change from baseline clinical attachment level at 12th month', 'timeFrame': 'Baseline to 12th month', 'description': 'Clinical attachment level (CAL) was measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonsurgical periodontal therapy', 'Orthodontic bands'], 'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '8634210', 'type': 'BACKGROUND', 'citation': 'Babay N, Al Jasser N. Subgingival irrigation effects of chlorhexidine or sanguinarine on gingivitis in orthodontic patients. J Clin Pediatr Dent. 1996 Spring;20(3):225-8.'}, {'pmid': '1590289', 'type': 'BACKGROUND', 'citation': 'Morrow D, Wood DP, Speechley M. Clinical effect of subgingival chlorhexidine irrigation on gingivitis in adolescent orthodontic patients. Am J Orthod Dentofacial Orthop. 1992 May;101(5):408-13. doi: 10.1016/0889-5406(92)70113-O.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.', 'detailedDescription': 'A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.\n\nGroup A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.\n\nGroup B comprised of 15 patients who were treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.\n\nParameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. The differences between the values were assessed and sent for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both male and female patients within the age group 16 to 25 years.\n2. Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.\n3. Systemically healthy patients.\n\nExclusion Criteria:\n\n1. Congenital malformations in the oral cavity.\n2. Patients who had undergone periodontal therapy within the previous 6 months.\n3. Patients using removable orthodontic appliances.\n4. Patients who were administered antibiotics or other systemic or topical antimicrobial agents.\n5. Smokers.'}, 'identificationModule': {'nctId': 'NCT03410602', 'briefTitle': 'Nonsurgical Periodontal Therapy on Banded First Molars', 'organization': {'class': 'OTHER', 'fullName': 'Meenakshi Ammal Dental College and Hospital'}, 'officialTitle': 'Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment', 'orgStudyIdInfo': {'id': 'MADC/IRB-IX/2016/153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Supragingival and subgingival scaling', 'description': 'Supragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.', 'interventionNames': ['Procedure: Full-mouth supragingival scaling', 'Procedure: Subgingival scaling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subgingival irrigation', 'description': 'Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.', 'interventionNames': ['Procedure: Full-mouth supragingival scaling', 'Procedure: Subgingival scaling', 'Drug: Subgingival irrigation']}], 'interventions': [{'name': 'Full-mouth supragingival scaling', 'type': 'PROCEDURE', 'otherNames': ['Oral prophylaxis'], 'description': 'Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.', 'armGroupLabels': ['Subgingival irrigation', 'Supragingival and subgingival scaling']}, {'name': 'Subgingival scaling', 'type': 'PROCEDURE', 'otherNames': ['Deep scaling'], 'description': 'Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.', 'armGroupLabels': ['Subgingival irrigation', 'Supragingival and subgingival scaling']}, {'name': 'Subgingival irrigation', 'type': 'DRUG', 'otherNames': ['Chemical plaque control'], 'description': 'Test group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.', 'armGroupLabels': ['Subgingival irrigation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nashra Kareem, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meenakshi Ammal Dental College and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meenakshi Ammal Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr.Jaideep Mahendra', 'investigatorAffiliation': 'Meenakshi Ammal Dental College and Hospital'}}}}