Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04870658
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2021-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient's Perception of Complications in Implantology.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient´s pain perception', 'timeFrame': 'Day 0', 'description': 'The degree of pain perceived by the patient after the onset of the complication by Numeric Rating Scale (NRS) form 0 to 10, being 0 "No pain" and 10 "Very painful".'}, {'measure': 'Functional impairment', 'timeFrame': 'Day 0', 'description': 'The impact of complication on functional impairment by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not affected" and 10 "Very affected".'}, {'measure': 'Degree of Concern', 'timeFrame': 'Day 0', 'description': 'The degree of concern that the complication generates in the patient by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not concerned" and 10 "Very concerned".'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'Day 0', 'description': 'Patient perception of the impact of the complication on their quality of life by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not affected" and 10 "Very affected".'}, {'measure': 'Degree of Confidence', 'timeFrame': 'Day 0', 'description': 'The impact that the complication has had on the patient\'s confidence in dental implant treatment using a numerical rating scale (NRS) from 0 to 10, with 0 being "Confident that they will not receive any further dental implant treatment" and 10 being "Confident that they will".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complication', 'Implant dentistry'], 'conditions': ['Dental Implant Failed', 'Dental Prosthesis Failure']}, 'referencesModule': {'references': [{'pmid': '32645229', 'type': 'BACKGROUND', 'citation': "Brunello G, Gervasi M, Ricci S, Tomasi C, Bressan E. Patients' perceptions of implant therapy and maintenance: A questionnaire-based survey. Clin Oral Implants Res. 2020 Oct;31(10):917-927. doi: 10.1111/clr.13634. Epub 2020 Jul 26."}, {'pmid': '25123298', 'type': 'BACKGROUND', 'citation': 'Derks J, Hakansson J, Wennstrom JL, Klinge B, Berglundh T. Patient-reported outcomes of dental implant therapy in a large randomly selected sample. Clin Oral Implants Res. 2015 May;26(5):586-91. doi: 10.1111/clr.12464. Epub 2014 Aug 14.'}, {'pmid': '28548884', 'type': 'BACKGROUND', 'citation': 'Insua A, Monje A, Wang HL, Inglehart M. Patient-Centered Perspectives and Understanding of Peri-Implantitis. J Periodontol. 2017 Nov;88(11):1153-1162. doi: 10.1902/jop.2017.160796. Epub 2017 May 26.'}, {'pmid': '32794289', 'type': 'BACKGROUND', 'citation': 'Karlsson K, Derks J, Wennstrom JL, Petzold M, Berglundh T. Occurrence and clustering of complications in implant dentistry. Clin Oral Implants Res. 2020 Oct;31(10):1002-1009. doi: 10.1111/clr.13647. Epub 2020 Sep 4.'}]}, 'descriptionModule': {'briefSummary': "To assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment.", 'detailedDescription': "The study is carried out in 5 dental centers with similar socio-professional characteristics.\n\nThe perception of patients with complications in implantology will be evaluated using a questionnaire.\n\nAll patients who present some type of complication in a dental treatment with implants will be included. Patients will be included both if they are aware of the complication, that is, they come to the consultation for it, and patients who are diagnosed with a complication in a routine check-up.\n\nPatients will be informed of the complication and before explaining the treatment possibilities, their inclusion in the study will be formalized by signing the Informed Consent document.\n\nSubsequently, they must fill out a questionnaire consisting of 5 questions about their perception of the complication and its influence on their quality of life.\n\nThe researcher will record the technical data of the implant treatment as well as the patient's responses in the Data Table.\n\nAfter collecting a sufficient number of data, around 400 patients, the collaborating researchers will send their corresponding data tables to the main researcher who will be in charge of the statistical analysis together with obtaining the results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients who present dental implant complication in any of the center in the study.', 'genderDescription': 'Male or female.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients form 18 to 95 years old. Patients with dental implants supporting one o more implant prosthesis. Patients presenting one treatment complication affecting either dental implant or implant prothesis.\n\nExclusion Criteria:\n\nPatients who does not accept informed consent and do not want to fill the questionnaire.\n\nPatients with cognitive impairment. Patients under psychiatric treatment.'}, 'identificationModule': {'nctId': 'NCT04870658', 'briefTitle': "Patient's Perception of Complications in Implantology.", 'organization': {'class': 'OTHER', 'fullName': 'Aula Dental Avanzada'}, 'officialTitle': "Patient's Perception of Complications in Implantology. Prospective Multicenter Study.", 'orgStudyIdInfo': {'id': 'COMPLI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complication', 'description': 'Any patients with biological or mechanical complication in dental implant treatment.', 'interventionNames': ['Procedure: Dental implant treatment']}], 'interventions': [{'name': 'Dental implant treatment', 'type': 'PROCEDURE', 'otherNames': ['Dental implant prosthesis'], 'description': 'Patients who receive one o more dental implant treatment to restore oral function.', 'armGroupLabels': ['Complication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03001', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Clínica Dental Esteve', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'overallOfficials': [{'name': 'Guillem Esteve-Pardo, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aula Dental Avanzada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aula Dental Avanzada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guillem Esteve-Pardo', 'investigatorAffiliation': 'Aula Dental Avanzada'}}}}