Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study

Completed

• Conditions: Peri-implant Mucositis; Peri-Implantitis; Questionnaires; Perception; Survey
• Interventions: Other: Questionnaire

• Registration Number: NCT06383351
• Lead Sponsor: University of Siena

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 Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-20
• Study First Posted: 2024-04-25
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Age between 18 and 70 years old;
• Presence of at least one dental implant;
• Presence of bleeding and/or suppuration upon probing of the peri-implant mucosa;
• Ability and willingness to provide written consent for participation in the study.

Exclusion Criteria

• Pregnancy or breastfeeding status;
• Patients unable to communicate in Italian or English;
• Inability to perform proper oral hygiene maneuvers;
• Inability or unwillingness to provide written consent for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peri-implant disease patients	Questionnaire	Patients with a diagnosis of peri-implant mucositis or peri-implantitis

Primary Outcome Measures

Name	Time	Method
Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ)	Baseline	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).
Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14.	Baseline	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).

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy