Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Plaque
• Intervention / Treatment: Device: NeoPill Oral Hygiene 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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgina Kyriakoudes; Phone Number: +35795112337; Email: aria@myaria.health
• Study Contact Backup: Name: Constantinos Zamboglou; Phone Number: 00357 25208000; Email: validate@gmic-eu.com

Study Locations

• Cyprus
  • Limassol, Cyprus, 4108
    • Recruiting
    • German Medical Institute
    • Contact: Constantina Cloconi; Phone Number: 0035725208000; Email: constantina.cloconi@goc.com.cy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NeoPill Device Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before and immediately after the intervention (same study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after device use (same study visit)

Collaborators and Investigators

• Sponsor: Neofunction d.o.o.
• Collaborators: German Oncology Center, Cyprus
• Investigators: Study Director: Constantinos Zamboglou, GMIC

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Actual): March 21, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dental plaque; Orthodontic appliances; Oral bacterial load; Oral hygiene device; Mechanical oral cleaning
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: ЕЕВК/ЕП/2025/72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No