Peri-implant MucositisNCT06383351
Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study
An observational study of Peri-implant Mucositis and Perception, run by University of Siena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peri-implant Mucositis, Perception, Survey
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 148 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2024to 27 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception and Impact on Oral Health-related Quality of Life 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).
Read the 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).
- Conditions
- Peri-implant Mucositis, Perception, Survey, Questionnaires, Peri-Implantitis
- Being tested
- Questionnaire
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant disease patients | Patients with a diagnosis of peri-implant mucositis or peri-implantitis Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start16 Apr 2024
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, DDS, MsC, PhD, Principal investigator, Department of Medical Biotechnologies, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383351
- Sponsor's protocol ID
- BQ001
- Status last verified
- Sep 2025
- First submitted
- 16 Apr 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9332805Machado 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.
PubMed 31446628Discepoli 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.
PubMed 33997985De 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.
PubMed 40827002
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception and Impact on Oral Health-related Quality of Life of Peri-implant Diseases. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06383351
- Acronym / sponsor ID
- BQ001
- Conditions
- Peri-implant Mucositis, Perception, Survey, Questionnaires, Peri-Implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peri-implant disease patients | – | Other: QuestionnairePatients with a diagnosis of peri-implant mucositis or peri-implantitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTwo 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. | Other | Peri-implant disease patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 9332805Slade 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.
- Background: PubMed 31446628Machado 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.
- Background: PubMed 33997985Discepoli 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.
- Derived from this study: PubMed 40827002De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Discepoli, DDS, MsC, PhD principal investigator
Department of Medical Biotechnologies, University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implant Mucositis and Perception, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06383351, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.