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:
University of Siena
Organization:
Study Overview
Official Title:
Perception and Impact on Oral Health-related Quality of Life of Peri-implant Diseases. A Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: