Dental PlaqueNCT07355400
Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
A study testing NeoPill Oral Hygiene Device in people with Dental Plaque, run by Neofunction d.o.o. at 1 site in Cyprus.
Trial summary
This study evaluates the effectiveness of the NeoPill oral hygiene device in reducing oral bacterial load in adults wearing fixed orthodontic appliances. Maintaining oral hygiene is challenging for orthodontic patients due to limited access around brackets and wires, and current solutions often rely on chemical-based… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- NeoPill Oral Hygiene Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCyprus
- Study dates
- 9 Dec 2025to Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Currently wearing fixed orthodontic appliances
- Able and willing to provide written informed consent
- Able to comply with study procedures during a single study visit
Who cannot join
- Use of systemic antibiotics within the past 2 weeks
- Presence of active oral infections
- Known immunocompromised status
- Presence of systemic medical conditions that may affect oral bacterial flora
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
German Medical Institute
Limassol, 4108
Constantina Cloconi, 0035725208000, constantina.cloconi@goc.com.cy
About this study
This study evaluates the effectiveness of the NeoPill oral hygiene device in reducing oral bacterial load in adults wearing fixed orthodontic appliances. Maintaining oral hygiene is challenging for orthodontic patients due to limited access around brackets and wires, and current solutions often rely on chemical-based products and disposable tools.
NeoPill is a reusable, battery-operated oral device designed to provide mechanical cleansing of the oral cavity. In this single-arm clinical evaluation, participants will undergo oral swab sampling before and immediately after a single 30-second application of the NeoPill device. The primary outcome is the change in aerobic bacterial load, measured as colony-forming units (CFUs), between pre- and post-treatment samples.
Participants will also complete a short questionnaire to assess usability, comfort, and overall experience with the device. The study aims to generate preliminary clinical and user-experience data to support further development of the NeoPill device.
Read the detailed description
This is a single-arm, pre-post interventional clinical evaluation designed to assess the effectiveness of the NeoPill device in reducing aerobic bacterial load in the oral cavity of adults with fixed orthodontic appliances. The study will be conducted at the German Medical Institute in Limassol, Cyprus, and will enroll approximately 15 to 20 participants aged 18 years or older.
Eligible participants must be currently wearing fixed orthodontic appliances and able to provide informed consent. Exclusion criteria include recent antibiotic use, active oral infections, immunocompromised status, or systemic conditions that may affect oral flora.
After providing written informed consent, participants will undergo baseline oral swab collection from gingival areas and around orthodontic brackets on the upper second premolars. A trained research technician or nurse will then apply the NeoPill device for a standardized duration of 30 seconds, ensuring consistent positioning and technique across participants. Immediately following device application, a second oral swab will be collected from the same anatomical sites.
Both swab samples will be transported under controlled conditions to an accredited microbiology laboratory at the German Medical Institute, where aerobic culturing will be performed to quantify colony-forming units (CFUs). The primary outcome measure is the difference in CFU counts between pre- and post-intervention samples. Statistical analysis will be conducted using a Wilcoxon Signed Rank Test with a significance threshold of p < 0.05.
Following sample collection, participants will complete a structured questionnaire assessing comfort, usability, perceived experience, and willingness to use the NeoPill device regularly. Questionnaire data and laboratory results will be linked using study-specific identifiers and stored securely within a GDPR-compliant digital platform.
The study involves minimal risk to participants, limited primarily to temporary discomfort during swab collection or device use. No chemical agents or systemic interventions are involved. All data will be pseudonymised prior to analysis, and only anonymised results will be shared with the device manufacturer.
- Conditions
- Dental Plaque
- Being tested
- NeoPill Oral Hygiene Device
- Keywords
- Dental plaque, Oral bacterial load, Orthodontic appliances, Oral hygiene device, Mechanical oral cleaning
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoPill Oral Hygiene DeviceDevice
The NeoPill is a reusable, battery-operated oral hygiene device applied intraorally for a standardized duration of 30 seconds. In this study, the device is applied once by trained study personnel. The intervention involves no chemical agents and no systemic exposure. The device is used to mechanically clean the oral cavity prior to post-intervention oral swab collection.
| Study group | Role | What they receive |
|---|---|---|
| NeoPill Device Intervention | Experimental | Participants in this single-arm study receive a single standardized 30-second application of the NeoPill oral hygiene device. Oral swab samples are collected immediately before and after device use to assess changes in aerobic bacterial load. Receives: Device: NeoPill Oral Hygiene Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic oral bacterial load
Difference in aerobic bacterial colony-forming unit (CFU) counts measured from oral swab samples collected immediately before and immediately after a single 30-second application of the NeoPill device.
Measured: Immediately before and immediately after the intervention (same study visit)
Secondary outcomes (1)
Participant-reported usability and comfort of the NeoPill device
Participant-reported usability and comfort are assessed using a NeoPill Participant Usability and Comfort Questionnaire, a structured, study-specific survey administered immediately after device use.
The composite usability score is derived from Likert-scale items assessing overall experience, discomfort/pain, and likelihood of future use.
- Overall experience is rated on a 5-point Likert scale ranging from 1 (Very Unpleasant) to 5 (Very Pleasant).
Higher scores indicate a more positive user experience.
- Discomfort or pain during device use is rated on a 5-point Likert scale ranging from 1 (No Pain) to 5 (Severe Pain).
Higher scores indicate greater discomfort.
- Likelihood of regular future use is rated on a 5-point Likert scale ranging from 1 (Very Unlikely) to 5 (Very Likely).
Higher scores indicate greater acceptability and usability.
Responses are combined descriptively to evaluate overall usability and comfort of the NeoPill device.
Measured: Immediately after device use (same study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Dec 2025
- Primary completion21 Mar 2026
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, pre-post interventional study in which all participants receive a single standardized 30-second application of the NeoPill device. Oral bacterial load is assessed before and immediately after the intervention using paired oral swab samples.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neofunction d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Oncology Center, Cyprus
- Responsible party
- Sponsor
- Investigators
- Constantinos Zamboglou, Study director, GMIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355400
- Sponsor's protocol ID
- ЕЕВК/ЕП/2025/72
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because all study data are pseudonymised and analysed for the specific purposes defined in the study protocol and ethics approval, with no provision for secondary data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT07355400
- Acronym / sponsor ID
- ЕЕВК/ЕП/2025/72
- Conditions
- Dental Plaque
- Keywords
- Dental plaque, Oral bacterial load, Orthodontic appliances, Oral hygiene device, Mechanical oral cleaning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Neofunction d.o.o.Industry (pharma, biotech, devices)
- Collaborators
- German Oncology Center, Cyprus
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Jan 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 study evaluates the effectiveness of the NeoPill oral hygiene device in reducing oral bacterial load in adults wearing fixed orthodontic appliances. Maintaining oral hygiene is challenging for orthodontic patients due to limited access around brackets and wires, and current solutions often rely on chemical-based products and disposable tools.
NeoPill is a reusable, battery-operated oral device designed to provide mechanical cleansing of the oral cavity. In this single-arm clinical evaluation, participants will undergo oral swab sampling before and immediately after a single 30-second application of the NeoPill device. The primary outcome is the change in aerobic bacterial load, measured as colony-forming units (CFUs), between pre- and post-treatment samples.
Participants will also complete a short questionnaire to assess usability, comfort, and overall experience with the device. The study aims to generate preliminary clinical and user-experience data to support further development of the NeoPill device.
Detailed description
This is a single-arm, pre-post interventional clinical evaluation designed to assess the effectiveness of the NeoPill device in reducing aerobic bacterial load in the oral cavity of adults with fixed orthodontic appliances. The study will be conducted at the German Medical Institute in Limassol, Cyprus, and will enroll approximately 15 to 20 participants aged 18 years or older.
Eligible participants must be currently wearing fixed orthodontic appliances and able to provide informed consent. Exclusion criteria include recent antibiotic use, active oral infections, immunocompromised status, or systemic conditions that may affect oral flora.
After providing written informed consent, participants will undergo baseline oral swab collection from gingival areas and around orthodontic brackets on the upper second premolars. A trained research technician or nurse will then apply the NeoPill device for a standardized duration of 30 seconds, ensuring consistent positioning and technique across participants. Immediately following device application, a second oral swab will be collected from the same anatomical sites.
Both swab samples will be transported under controlled conditions to an accredited microbiology laboratory at the German Medical Institute, where aerobic culturing will be performed to quantify colony-forming units (CFUs). The primary outcome measure is the difference in CFU counts between pre- and post-intervention samples. Statistical analysis will be conducted using a Wilcoxon Signed Rank Test with a significance threshold of p < 0.05.
Following sample collection, participants will complete a structured questionnaire assessing comfort, usability, perceived experience, and willingness to use the NeoPill device regularly. Questionnaire data and laboratory results will be linked using study-specific identifiers and stored securely within a GDPR-compliant digital platform.
The study involves minimal risk to participants, limited primarily to temporary discomfort during swab collection or device use. No chemical agents or systemic interventions are involved. All data will be pseudonymised prior to analysis, and only anonymised results will be shared with the device manufacturer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, pre-post interventional study in which all participants receive a single standardized 30-second application of the NeoPill device. Oral bacterial load is assessed before and immediately after the intervention using paired oral swab samples.
| Arm | Type | Receives |
|---|---|---|
| NeoPill Device Intervention | Experimental | Device: NeoPill Oral Hygiene DeviceParticipants in this single-arm study receive a single standardized 30-second application of the NeoPill oral hygiene device. Oral swab samples are collected immediately before and after device use to assess changes in aerobic bacterial load. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Currently wearing fixed orthodontic appliances
- Able and willing to provide written informed consent
- Able to comply with study procedures during a single study visit
Key exclusion criteria (4 listed)
- Use of systemic antibiotics within the past 2 weeks
- Presence of active oral infections
- Known immunocompromised status
- Presence of systemic medical conditions that may affect oral bacterial flora
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 |
|---|---|---|
| NeoPill Oral Hygiene DeviceThe NeoPill is a reusable, battery-operated oral hygiene device applied intraorally for a standardized duration of 30 seconds. In this study, the device is applied once by trained study personnel. The intervention involves no chemical agents and no systemic exposure. The device is used to mechanically clean the oral cavity prior to post-intervention oral swab collection. | Device | NeoPill Device Intervention |
Primary outcome
Change in aerobic oral bacterial load
Time frame: Immediately before and immediately after the intervention (same study visit)
Difference in aerobic bacterial colony-forming unit (CFU) counts measured from oral swab samples collected immediately before and immediately after a single 30-second application of the NeoPill device.
1 secondary outcome
Participant-reported usability and comfort of the NeoPill device
Time frame: Immediately after device use (same study visit)
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 9 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because all study data are pseudonymised and analysed for the specific purposes defined in the study protocol and ethics approval, with no provision for secondary data sharing.
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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.
Constantinos Zamboglou study director
GMIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoPill Oral Hygiene Device in people with Dental Plaque, run by Neofunction d.o.o. at 1 site in Cyprus.
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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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 Cyprus. 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?
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?
Contact Georgina Kyriakoudes (+35795112337, aria@myaria.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aerobic oral bacterial load (time frame: Immediately before and immediately after the intervention (same study visit)). 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 9 Apr 2026.