Peri-implant MucositisNCT07393828
Effectiveness of Interproximal Cleaning Devices for Biofilm Removal Around Posterior Single Implants With Peri-Implant Mucositis
A study of Peri-implant Mucositis, run by Universitat Internacional de Catalunya.
Trial summary
This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-implant Mucositis
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged ≥18 years. Presence of at least one posterior single dental implant in function for ≥12 months.
- Diagnosis of peri-implant mucositis, defined as bleeding on probing with probing depths ≤5 mm and no radiographic bone loss beyond initial remodeling.
- Good general health (ASA I-II). Ability and willingness to comply with study procedures and follow-up visits. Provision of written informed consent.
Who cannot join
- Diagnosis of peri-implantitis (radiographic bone loss beyond initial remodeling).
- Uncontrolled systemic diseases affecting periodontal or peri-implant health (e.g., uncontrolled diabetes mellitus).
- Use of systemic antibiotics or anti-inflammatory drugs within the previous 3 months.
- Current pregnancy or lactation. Current smoker of >10 cigarettes/day. History of periodontal therapy or professional implant maintenance within the previous 3 months.
- Use of medications known to affect bone metabolism (e.g., bisphosphonates). Inability to perform adequate oral hygiene or to attend scheduled study visits.
About this study
Official title: Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants in Peri-Implant Mucositis: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis.
Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites.
Read more
A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline.
Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants.
The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.
- Conditions
- Peri-implant Mucositis
- Being tested
- Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (interDevice
Participants will receive a structured oral hygiene intervention using interproximal oral hygiene devices specifically designed for use around posterior single implants diagnosed with peri-implant mucositis. The intervention consists of standardized instruction and supervised use of the assigned interproximal device according to manufacturer recommendations and a predefined clinical protocol. The device will be used by participants for daily interproximal plaque control around the implant site throughout the study period. Clinical and microbiological outcomes related to biofilm accumulation and peri-implant soft tissue inflammation will be assessed at predefined follow-up visits. No pharmacological agents are administered as part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Interdental Brush Group | Experimental | Participants use interdental brushes for interproximal plaque control around posterior implants. Receives: Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter |
| Oral Irrigator Group | Experimental | Participants use an oral irrigator for interproximal plaque control around posterior implants. Receives: Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter |
| Superfloss Group | Experimental | Participants use Superfloss for interproximal plaque control around posterior implants. Receives: Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant biofilm accumulation
Change in interproximal peri-implant biofilm accumulation measured using a validated plaque index (e.g., Modified Plaque Index) at posterior single implants.
Measured: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Change in peri-implant biofilm accumulation
The primary outcome measure is the change in peri-implant biofilm accumulation following the use of the assigned interproximal oral hygiene device. Biofilm levels will be assessed at implant-supported posterior sites using a validated plaque index specific for peri-implant tissues. Measurements will be recorded at baseline and after the intervention period, and the difference between time points will be used for analysis.
Measured: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Secondary outcomes (1)
Change in peri-implant probing pocket depth
This secondary outcome assesses changes in peri-implant probing pocket depth (PPD) following the use of different interproximal oral hygiene devices. Probing depth will be measured at standardized peri-implant sites using a calibrated periodontal probe, and changes from baseline will be analyzed to evaluate the clinical response of peri-implant tissues.
Measured: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393828
- Sponsor's protocol ID
- PER-ECL-2025-04
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants in Peri-Implant Mucositis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07393828
- Acronym / sponsor ID
- PER-ECL-2025-04
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis.
Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites.
A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline.
Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants.
The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interdental Brush Group | Experimental | Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (interParticipants use interdental brushes for interproximal plaque control around posterior implants. |
| Oral Irrigator Group | Experimental | Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (interParticipants use an oral irrigator for interproximal plaque control around posterior implants. |
| Superfloss Group | Experimental | Device: Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (interParticipants use Superfloss for interproximal plaque control around posterior implants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years. Presence of at least one posterior single dental implant in function for ≥12 months.
- Diagnosis of peri-implant mucositis, defined as bleeding on probing with probing depths ≤5 mm and no radiographic bone loss beyond initial remodeling.
- Good general health (ASA I-II). Ability and willingness to comply with study procedures and follow-up visits. Provision of written informed consent.
Key exclusion criteria (5 listed)
- Diagnosis of peri-implantitis (radiographic bone loss beyond initial remodeling).
- Uncontrolled systemic diseases affecting periodontal or peri-implant health (e.g., uncontrolled diabetes mellitus).
- Use of systemic antibiotics or anti-inflammatory drugs within the previous 3 months.
- Current pregnancy or lactation. Current smoker of >10 cigarettes/day. History of periodontal therapy or professional implant maintenance within the previous 3 months.
- Use of medications known to affect bone metabolism (e.g., bisphosphonates). Inability to perform adequate oral hygiene or to attend scheduled study visits.
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 |
|---|---|---|
| Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (interParticipants will receive a structured oral hygiene intervention using interproximal oral hygiene devices specifically designed for use around posterior single implants diagnosed with peri-implant mucositis. The intervention consists of standardized instruction and supervised use of the assigned interproximal device according to manufacturer recommendations and a predefined clinical protocol. The device will be used by participants for daily interproximal plaque control around the implant site throughout the study period. Clinical and microbiological outcomes related to biofilm accumulation and peri-implant soft tissue inflammation will be assessed at predefined follow-up visits. No pharmacological agents are administered as part of the intervention. | Device | Interdental Brush Group, Oral Irrigator Group, Superfloss Group |
Primary outcome
Change in peri-implant biofilm accumulation
Time frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Change in interproximal peri-implant biofilm accumulation measured using a validated plaque index (e.g., Modified Plaque Index) at posterior single implants.
Change in peri-implant biofilm accumulation
Time frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
The primary outcome measure is the change in peri-implant biofilm accumulation following the use of the assigned interproximal oral hygiene device. Biofilm levels will be assessed at implant-supported posterior sites using a validated plaque index specific for peri-implant tissues. Measurements will be recorded at baseline and after the intervention period, and the difference between time points will be used for analysis.
1 secondary outcome
Change in peri-implant probing pocket depth
Time frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Peri-implant Mucositis, run by Universitat Internacional de Catalunya.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 peri-implant biofilm accumulation (time frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention). 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?
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 6 Feb 2026.