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

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).

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Key information

Conditions

Peri-implant Mucositis Mouth Diseases Perception Peri-Implantitis Periodontal Diseases Questionnaires Stomatognathic Diseases Survey

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUS

Siena, 53100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

Two sets of questionnaires will be administered to patients:

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);
Oral Health Impact Profile 14 (OHIP-14) questionnaire.

Primary outcomes

Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ)

Time frame: 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.

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

Perception and Impact on Oral Health-related Quality of Life of Peri-implant Diseases. A Cross-sectional Study

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Apr 25, 2024
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed