Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06811818
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2025-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003824', 'term': 'Denture, Complete'}], 'ancestors': [{'id': 'D003778', 'term': 'Dentures'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2025-01-19', 'studyFirstSubmitQcDate': '2025-02-02', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance', 'timeFrame': 'upto 24 weeks', 'description': 'The chewed material that has been sieved through 10-mesh sieve and dried through blotting paper for 30 minutes weighted using an electronic balance with a precision of 0.01 grams . Statistical analysis performed to evaluate masticatory efficiency based on the mean weight of chewed peanuts.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Masticatory performance , Bilateral balanced occlusion , Lingualized occlusion'], 'conditions': ['Masticatory Performance']}, 'descriptionModule': {'briefSummary': 'This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.', 'detailedDescription': 'This study is a randomized control trial to compare the masticatory efficiency of complete dentures with bilateral balanced occlusion with that of lingualized occlusion . Grouping of participants was carried out. Participants divided into two groups one receiving complete dentures with bilateral balanced occlusion and the other group receiving complete dentures with lingualized occlusion . Each participant provided with 15g of peanuts and instructed to chew until ready to swallow . The chew material than spat into the designated container and participants asked to rinse their mouth with water , with the rinse being collected in the same container . The collected material than sieved through 10-Mesh sieve followed by drying the sieved content on blotting paper for 30 minutes. The dried material subsequently weight with an electric balance with precision of 0.01 grams . Masticatory efficiency assessed through mean weight of chewed peanuts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants aged 45-65 years.\n2. Both genders included.\n3. Edentulous patients requiring complete denture.\n4. Patients willing to participate in the study .\n\nExclusion Criteria:\n\n1. Participants not willing to participate in the study.\n2. Participants with systemic disease .\n3. Participants with neuromuscular disorders .'}, 'identificationModule': {'nctId': 'NCT06811818', 'briefTitle': 'Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Dentistry, Pakistan'}, 'officialTitle': 'Comparison of Masticatory Performance of Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture Patients', 'orgStudyIdInfo': {'id': 'masticatory performance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'complete denture with bilateral balanced occlusion', 'description': 'complete denture with bilateral balanced occlusion', 'interventionNames': ['Other: complete denture with bilateral balanced occlusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'complete denture with lingualized occlusion', 'description': 'complete denture with lingualized occlusion', 'interventionNames': ['Other: complete denture with lingualized occlusion']}], 'interventions': [{'name': 'complete denture with bilateral balanced occlusion', 'type': 'OTHER', 'description': 'Participants in this group will be given complete dentures with bilateral balanced occlusion', 'armGroupLabels': ['complete denture with bilateral balanced occlusion']}, {'name': 'complete denture with lingualized occlusion', 'type': 'OTHER', 'description': 'Participants in this group will be given complete dentures with lingualized occlusion', 'armGroupLabels': ['complete denture with lingualized occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Armed Forces Institute Of Dentistry', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Seema Khattak, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Forces Institute of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Dentistry, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Seema Khattak , Principal Investigator and Resident Prosthodontics', 'investigatorFullName': 'Seema Khattak', 'investigatorAffiliation': 'Armed Forces Institute of Dentistry, Pakistan'}}}}