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

NCT ID: NCT06383351

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-16

Study Completion Date

2024-06-27

Brief Summary

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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

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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).

Conditions

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Peri-implant Mucositis Perception Survey Questionnaires Peri-Implantitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Peri-implant disease patients

Patients with a diagnosis of peri-implant mucositis or peri-implantitis

Questionnaire

Intervention Type 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.

Interventions

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Questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Nicola Discepoli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Discepoli, DDS, MsC, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Biotechnologies, University of Siena

Locations

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AOUS

Siena, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 9332805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31446628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33997985 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40827002 (View on PubMed)

Other Identifiers

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BQ001

Identifier Type: -

Identifier Source: org_study_id

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