NCT06383351

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

April 16, 2024

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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).

    Baseline

  • Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14.

    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).

    Baseline

Study Arms (1)

Peri-implant disease patients

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

Other: Questionnaire

Interventions

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.

Peri-implant disease patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

Related Publications (4)

  • 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.

    PMID: 9332805BACKGROUND
  • 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.

    PMID: 31446628BACKGROUND
  • 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.

    PMID: 33997985BACKGROUND
  • 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.

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nicola Discepoli, DDS, MsC, PhD

    Department of Medical Biotechnologies, University of Siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 25, 2024

Study Start

April 16, 2024

Primary Completion

June 27, 2024

Study Completion

June 27, 2024

Last Updated

September 4, 2025

Record last verified: 2025-09

Locations