Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-09 @ 8:55 PM
Study NCT ID:
NCT01597206
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2012-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventions for Patients With a Shortened Dental Arch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003832', 'term': 'Denture, Partial, Removable'}], 'ancestors': [{'id': 'D003829', 'term': 'Denture, Partial'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Negative outcomes with intervention', 'timeFrame': '3 months', 'description': 'These include: periodontal breakdown (plaque index, loss of attachment), tooth loss, carious lesion formation, change in treatment or any other self-reported complaints'}], 'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '3 months', 'description': 'Two different tools will b used to assess primary outcomes\n\n1. Oral Impact of Daily Performance (OIDP) tool\n2. Global Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Functioning', 'timeFrame': '3 months', 'description': 'Failure of intervention or patient unhappy with treatment prescribed'}, {'measure': 'Oral health-related Quality of Life', 'timeFrame': '3 months', 'description': 'A Tool will be used to assess primary outcome'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['randomized controlled trial', 'intervention', 'posterior reduced dental arch', 'patient satisfaction', 'sequential sampling'], 'conditions': ['Anomaly of Dental Arch']}, 'descriptionModule': {'briefSummary': 'Dental services for large sectors of the population of the Western Cape (WC) Province of South Africa (SA) has been, and continues to be, limited to low-cost treatment options and emergency services, such as extractions at public health clinics. Replacement of missing teeth for the disadvantaged majority of the population is provided almost exclusively at the dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result of disease and the lack of restorative care and then having these replaced by a removable partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and quality of life of partially dentate adult patients with a reduced posterior dental arch and /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the posterior teeth with a removable prosthesis.', 'detailedDescription': 'The aim of this research is to determine whether the daily functional needs and the quality of life of partially dentate adult patients with a reduced posterior dental arch will be satisfied and improved without having the posterior teeth replaced with a removable prosthesis, as compared to having the use of such prosthesis.\n\nObjectives: To conduct a randomized controlled trial amongst partially dentate adult patients with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and where these patients will be randomly assigned to one of two groups: one group would be provided with a metal- based removable partial denture (RPDP) to replace the posterior teeth, the other will receive no treatment.\n\nDaily functioning ability and patient satisfaction between the groups (with/without RPDP) would then be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Classic SDA\n* Patients with a reduced posterior dental arch (from 3-5 posterior occluding teeth)\n* Specific Age limits\n* Remaining teeth periodontally sound\n* Lost molars in one jaw\n* Both canines and one premolar should be present\n\nExclusion Criteria:\n\n* Exclude patients with Angle Class 2 or 3\n* Signs of Temporo-mandibular disorders\n* Compliance is a problem (Alcoholism/ drug addiction)\n* Risk of over-eruption of teeth\n* Patients wanting removable partial dentures'}, 'identificationModule': {'nctId': 'NCT01597206', 'acronym': 'SDA-RCT', 'briefTitle': 'Interventions for Patients With a Shortened Dental Arch', 'organization': {'class': 'OTHER', 'fullName': 'University of the Western Cape'}, 'officialTitle': 'Outcomes of Interventions for Patients With a Reduced Posterior Dental Arch: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SDA Clinical Trial'}, 'secondaryIdInfos': [{'id': 'SDA South African RCT', 'type': 'OTHER', 'domain': 'UWC- SA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Removable partial denture Group', 'description': 'Patients with a reduced posterior dental arch will be randomized into one of 2 Groups Group A will receive a removable partial denture prosthesis', 'interventionNames': ['Device: Removable partial denture (Chrome Cobalt Distal extension)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reduced Posterior Dental Arch Group', 'description': 'Patients with a reduced posterior dental arch and not receiving any Intervention will be compared to the removable partial denture group', 'interventionNames': ['Other: A reduced posterior dental arch']}], 'interventions': [{'name': 'Removable partial denture (Chrome Cobalt Distal extension)', 'type': 'DEVICE', 'otherNames': ['Chrome Cobalt Distal extension denture for Group A patients'], 'description': 'For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch', 'armGroupLabels': ['Removable partial denture Group']}, {'name': 'A reduced posterior dental arch', 'type': 'OTHER', 'otherNames': ['No intervention for Group B patients'], 'description': 'For Group B: Patients with a reduced posterior dental arch will not be provided with a removable denture and will be compared to patients in Group A', 'armGroupLabels': ['Reduced Posterior Dental Arch Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Saadika Khan', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Saadika Khan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff Member'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'By publishing the results in a reputable (peer reviewed and accredited) journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Western Cape', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Saadika Khan', 'investigatorAffiliation': 'University of the Western Cape'}}}}