Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-26 @ 8:22 PM
Study NCT ID:
NCT04930835
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D000848', 'term': 'Anodontia'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019094', 'term': 'Dental Prosthesis, Implant-Supported'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance of Dental implants', 'timeFrame': 'One year after treatment', 'description': 'Implant failure rate'}, {'measure': 'Oral health-related quality of life', 'timeFrame': 'One year after treatment', 'description': 'impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.'}, {'measure': 'Mastication', 'timeFrame': 'One year after treatment', 'description': 'Mixing ability tests'}, {'measure': 'Area of Occlusal Occlusion', 'timeFrame': 'One year after treatment', 'description': 'According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters'}, {'measure': 'Occlusal Load', 'timeFrame': 'One year after treatment', 'description': 'According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Jaw', 'Missing Teeth']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.\n* sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)\n* no evidence of systemic or psychic pathology that might contraindicate the implant treatment.\n\nExclusion Criteria:\n\n* Those in which oral surgery or cognitive evaluations are contraindicated'}, 'identificationModule': {'nctId': 'NCT04930835', 'acronym': 'ILOD', 'briefTitle': 'Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ILOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Loading', 'description': 'implants are loaded at least after two months of healing', 'interventionNames': ['Procedure: Implant supported dentures']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Loading', 'description': 'implants are loaded the same day of surgery', 'interventionNames': ['Procedure: Implant supported dentures']}], 'interventions': [{'name': 'Implant supported dentures', 'type': 'PROCEDURE', 'description': 'Placement of dental implants with different loading protocols for supporting full arch dentures.', 'armGroupLabels': ['Conventional Loading', 'Immediate Loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Clinica Odontológica de la Universidad de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor in Prosthodontics at the University of Salamanca', 'investigatorFullName': 'JAVIER MONTERO', 'investigatorAffiliation': 'University of Salamanca'}}}}