Peri-implant MucositisNCT06901388
Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy
A study testing Non-surgical peri-implant therapy in people with Peri-implant Mucositis and Peri-Implantitis, run by University of Siena at 1 site in Italy.
Trial summary
The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- Non-surgical peri-implant therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 29 Jul 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Diagnosis of peri-implant disease requiring non-surgical therapy
- Presence of at least one dental implant loaded for a minimum of one year
- History of periodontitis
- Good general health
- Ability to provide written informed consen
Who cannot join
- Pregnant or lactating individuals
- Inability to perform basic oral hygiene procedures
- Inability to understand or complete study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy: A Pre-post Quasi-Experimental Study
The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Using validated psychometric tools, including the Brief Illness Perception Questionnaire (Brief-IPQ) and the Oral Health Impact Profile-14 (OHIP-14), the study evaluates patients at baseline and three months after therapy. The study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Being tested
- Non-surgical peri-implant therapy
- Keywords
- Oral Health Impact Profile 14, Brief-Illness Perception Questionnaire, Non-surgical peri-implant therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical peri-implant therapyProcedure or surgery
Also called Mechanical debridement + Oral hygiene instruction
Standardized non-surgical therapy consisting of mechanical debridement of peri-implant sites using ultrasonic instruments, combined with personalized oral hygiene instruction. The intervention is delivered in a single session. No adjunctive antimicrobials are used. Follow-up is scheduled 3 months after therapy for clinical and psychometric re-evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | All participants will receive non-surgical peri-implant therapy consisting of mechanical debridement and oral hygiene instruction. Psychometric assessments (Brief-IPQ and OHIP-14) will be administered at baseline and 3 months after treatment to evaluate changes in illness perception and oral health-related quality of life. Receives: Procedure: Non-surgical peri-implant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in illness perception (Brief-IPQ total score)
Illness perception will be assessed using the Brief Illness Perception Questionnaire (Brief-IPQ). The primary outcome is the change in the total score from baseline to 3 months after baseline, following non-surgical peri-implant therapy.
Measured: Baseline and 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start31 Mar 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901388
- Sponsor's protocol ID
- BIPP001
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy: A Pre-post Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT06901388
- Acronym / sponsor ID
- BIPP001
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- Oral Health Impact Profile 14, Brief-Illness Perception Questionnaire, Non-surgical peri-implant therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 28 Mar 2025 (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.
The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Using validated psychometric tools, including the Brief Illness Perception Questionnaire (Brief-IPQ) and the Oral Health Impact Profile-14 (OHIP-14), the study evaluates patients at baseline and three months after therapy. The study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Procedure: Non-surgical peri-implant therapyAll participants will receive non-surgical peri-implant therapy consisting of mechanical debridement and oral hygiene instruction. Psychometric assessments (Brief-IPQ and OHIP-14) will be administered at baseline and 3 months after treatment to evaluate changes in illness perception and oral health-related quality of life. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 80 years
- Diagnosis of peri-implant disease requiring non-surgical therapy
- Presence of at least one dental implant loaded for a minimum of one year
- History of periodontitis
- Good general health
Key exclusion criteria (3 listed)
- Pregnant or lactating individuals
- Inability to perform basic oral hygiene procedures
- Inability to understand or complete study questionnaires
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 |
|---|---|---|
| Non-surgical peri-implant therapyAlso: Mechanical debridement + Oral hygiene instructionStandardized non-surgical therapy consisting of mechanical debridement of peri-implant sites using ultrasonic instruments, combined with personalized oral hygiene instruction. The intervention is delivered in a single session. No adjunctive antimicrobials are used. Follow-up is scheduled 3 months after therapy for clinical and psychometric re-evaluation. | Procedure or surgery | Single group |
Primary outcome
Change in illness perception (Brief-IPQ total score)
Time frame: Baseline and 3 months from baseline
Illness perception will be assessed using the Brief Illness Perception Questionnaire (Brief-IPQ). The primary outcome is the change in the total score from baseline to 3 months after baseline, following non-surgical peri-implant therapy.
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 30 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical peri-implant therapy in people with Peri-implant Mucositis and Peri-Implantitis, 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 6 inclusion and 3 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 30 Jul 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?
Change in illness perception (Brief-IPQ total score) (time frame: Baseline and 3 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.