Clinical trial NCT06383351: Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study
Official title: Perception and Impact on Oral Health-related Quality of Life of Peri-implant Diseases. A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-implant Mucositis
Perception
Survey
Questionnaires
Peri-Implantitis
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited consecutively from those attending the Unit of Periodontics, Departoment of Medical Biotechnologies, at "Le Scotte" University Hospital (Siena, Italy).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ)
timeFrame: Baseline
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
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
affiliation: Department of Medical Biotechnologies, University of Siena
name: Nicola Discepoli, DDS, MsC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.