An interventional study of NeoPill Oral Hygiene Device in Dental Plaque, sponsored by Neofunction d.o.o.. Recruiting at 1 site in Cyprus. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Neofunction d.o.o. · Not applicable, Interventional, and Other
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.
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.
352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.
This study's planned enrollment of 15 is below the median of 56 across 316 interventional studies indexed under Dental Plaque.
Browse Dental Plaque studies →This is the only study on the registry with Neofunction d.o.o. as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: NeoPill Oral Hygiene Device
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.
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.
Time frame: Immediately before and immediately after the intervention (same study visit)
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.
Time frame: Immediately after device use (same study visit)
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Mar 2026, 3 months.
Of 45 industry-sponsored interventional studies with no phase under Dental Plaque, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 8. This study's 3 months is above that.
Counting every sponsor, half of 178 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
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