Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
Study NCT ID:
NCT05589532
Status:
TERMINATED
Last Update Posted:
2025-08-26
First Post:
2022-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Invibio Ltd decided to leave the market and stop PEEK production', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of the prosthesis', 'timeFrame': 'one year', 'description': 'Evaluation of the survival for the implant-supported crowns; nominal (survival,failure)'}], 'secondaryOutcomes': [{'measure': 'Survival of the implants', 'timeFrame': 'one year', 'description': 'Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)'}, {'measure': 'Incidence of biological complications', 'timeFrame': 'one year', 'description': 'Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)'}, {'measure': 'Incidence of mechanical complications', 'timeFrame': 'one year', 'description': 'Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)'}, {'measure': 'Marginal bone resorption', 'timeFrame': 'one year', 'description': 'Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale'}, {'measure': 'Denture staining', 'timeFrame': 'one year', 'description': 'Veneer staining; 0:heavily stained; 10: no stains'}, {'measure': 'Denture colour stability', 'timeFrame': 'one year', 'description': 'Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability'}, {'measure': 'Denture anatomic form', 'timeFrame': 'one year', 'description': 'Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.'}, {'measure': 'Patient tissue reaction', 'timeFrame': 'one year', 'description': 'Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'ln mouth comfort', 'timeFrame': 'one year', 'description': 'Patient in mouth comfort. Visual analogue scale (0-10 cm); 0:very poor; 10: very good'}, {'measure': 'Oral Health Impact Profile OHIP-14', 'timeFrame': 'one year', 'description': 'Oral Health Impact Profile OHIP-14 questionnaire'}, {'measure': 'Laboratory preparation time', 'timeFrame': 'one year', 'description': 'Average laboratory time to produce the finished prosthesis, the active technician time spent in Computer assisted design, Computer assisted manufacture, mill and veneering.'}, {'measure': 'Clinical operative time', 'timeFrame': 'one year', 'description': 'Average operative time to load the final prosthesis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prosthesis', 'dental implants', 'PEEK'], 'conditions': ['Prosthesis Survival']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:\n\n\\- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.', 'detailedDescription': 'Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using Single Crowns. To test this, the study design to be used will be a single centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including staining, colour stability and anatomical form; patient in mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs for economical purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients rehabilitated with a single crown supported by and implant in immediate function;\n* Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups;\n* Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant;\n* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;\n* Subjects who are currently enrolled in a clinical study;\n* Subjects requiring or currently having ongoing orthodontic treatment;'}, 'identificationModule': {'nctId': 'NCT05589532', 'acronym': 'PEEKPilotST', 'briefTitle': 'Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.', 'organization': {'class': 'OTHER', 'fullName': 'Malo Clinic'}, 'officialTitle': 'Rehabilitation of Single Teeth Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic Single Crowns Supported by Dental Implants', 'orgStudyIdInfo': {'id': 'PEEKPilotST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prosthetic single-tooth prosthesis using PEEK', 'description': 'An implant-supported single tooth prosthesis using a PEEK polymer in its composition', 'interventionNames': ['Device: Prosthetic single-tooth prosthesis using PEEK']}], 'interventions': [{'name': 'Prosthetic single-tooth prosthesis using PEEK', 'type': 'DEVICE', 'otherNames': ['PEEK prosthesis'], 'description': 'A single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis.', 'armGroupLabels': ['Prosthetic single-tooth prosthesis using PEEK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1600-042', 'city': 'Lisbon', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Malo Clinic', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Miguel A de Araújo Nobre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Research, Development and Education'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Upon study completion and for 8 years.', 'ipdSharing': 'YES', 'description': 'Anonymized database containing the study variables', 'accessCriteria': 'Upon solicitation to the Investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Invibio Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}