Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06383351
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2024-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-20', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ)", 'timeFrame': 'Baseline', 'description': "Brief Illness Perception Questionnaire consists of 9 questions, each one evaluated on a scale of 0 to 10 (minimum score of 0, maximum score of 90). Higher scores mean a higher patient's perception of the disease (higher scores mean worse outcome)."}, {'measure': "Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14.", 'timeFrame': 'Baseline', 'description': "14 questions about the impact of oral health on the quality of life; each question will be evaluated on a scale of 1 to 5 (minimum score of 0, maximum score of 70). Higher scores mean that patient's oral health impacts more significantly on their quality of life (higher scores, worse outcomes)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-implant Mucositis', 'Perception', 'Survey', 'Questionnaires', 'Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '9332805', 'type': 'BACKGROUND', 'citation': 'Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.'}, {'pmid': '31446628', 'type': 'BACKGROUND', 'citation': 'Machado V, Botelho J, Ramos C, Proenca L, Alves R, Cavacas MA, Mendes JJ. Psychometric properties of the Brief Illness Perception Questionnaire (Brief-IPQ) in periodontal diseases. J Clin Periodontol. 2019 Dec;46(12):1183-1191. doi: 10.1111/jcpe.13186. Epub 2019 Oct 21.'}, {'pmid': '33997985', 'type': 'BACKGROUND', 'citation': "Discepoli N, Marruganti C, Mirra R, Pettinari G, Ferrari Cagidiaco E, Ferrari M. Patients' illness perception before and after non-surgical periodontal therapy: A pre-post quasi-experimental study. J Periodontol. 2022 Jan;93(1):123-134. doi: 10.1002/JPER.21-0052. Epub 2021 May 25."}, {'pmid': '40827002', 'type': 'DERIVED', 'citation': 'De Rubertis I, Fratini A, Ferrari A, Mirra R, Discepoli N. Cognitive and Emotional Peri-Implant Diseases Perception in a Cohort of Periodontitis Patients: A University-Based Cross-Sectional Study. J Clin Periodontol. 2025 Nov;52(11):1573-1583. doi: 10.1111/jcpe.70011. Epub 2025 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at "Le Scotte" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14).', 'detailedDescription': 'Peri-implant diseases are inflammatory processes, influenced by biofilm, affecting the soft and hard tissues surrounding dental implants. They encompass two main conditions: peri-implant mucositis and peri-implantitis. While professional biofilm removal, coupled with plaque control, is considered the gold standard treatment, its efficacy is limited. Therefore, enhancing prevention and early diagnosis strategies for peri-implant complications is crucial. Despite extensive research on patient perception of periodontitis symptoms, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. This observational study aims to assess patient perception of peri-implant diseases and their impact on oral health-related quality of life (OHRQoL). The study is a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics, Department of Medical Biotechnologies, at "Le Scotte" University Hospital. Following diagnosis of peri-implant disease, patients meeting inclusion and exclusion criteria specified in the protocol will be included. Given the study\'s cross-sectional nature, no follow-up visits are planned. Validated questionnaires regarding the perception and impact on the quality of life of peri-implant diseases will be administered. Study procedures will include recording biometric parameters extracted from a complete periodontal examination and administering questionnaires on the perception and impact on the quality of life of peri-implant diseases: Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited consecutively from those attending the Unit of Periodontics, Departoment of Medical Biotechnologies, at "Le Scotte" University Hospital (Siena, Italy).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years old;\n* Presence of at least one dental implant;\n* Presence of bleeding and/or suppuration upon probing of the peri-implant mucosa;\n* Ability and willingness to provide written consent for participation in the study.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding status;\n* Patients unable to communicate in Italian or English;\n* Inability to perform proper oral hygiene maneuvers;\n* Inability or unwillingness to provide written consent for participation in the study.'}, 'identificationModule': {'nctId': 'NCT06383351', 'briefTitle': "Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study", 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Perception and Impact on Oral Health-related Quality of Life of Peri-implant Diseases. A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'BQ001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri-implant disease patients', 'description': 'Patients with a diagnosis of peri-implant mucositis or peri-implantitis', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Two sets of questionnaires will be administered to patients:\n\n* Questionnaire about their perception of peri-implant disease (Brief Illness Perception Questionnaire; 9 questions, answers will be registered on a scale of 0 to 10);\n* Oral Health Impact Profile 14 (OHIP-14) questionnaire.', 'armGroupLabels': ['Peri-implant disease patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'AOUS', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'overallOfficials': [{'name': 'Nicola Discepoli, DDS, MsC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Biotechnologies, University of Siena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}