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

NCT07355400 | Recruiting DMC

• 1 other identifier: ЕЕВК/ЕП/2025/72
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Plaque

Keywords

Dental plaque; Oral bacterial load; Orthodontic appliances; Oral hygiene device; Mechanical oral cleaning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant-reported usability and comfort of the NeoPill device

  Immediately after device use (same study visit)

Study Arms (1)

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.

Device: NeoPill Oral Hygiene Device

Interventions

NeoPill Oral Hygiene Device 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.

NeoPill Device Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neofunction d.o.o.: lead
• German Oncology Center, Cyprus: collaborator

Study Sites (1)

German Medical Institute

Limassol, 4108, Cyprus

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Constantinos Zamboglou

  GMIC

  STUDY DIRECTOR

Central Study Contacts

Georgina Kyriakoudes

CONTACT

+35795112337; aria@myaria.health

Constantinos Zamboglou

CONTACT

00357 25208000; validate@gmic-eu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 21, 2026
• Study Start: December 9, 2025
• Primary Completion: March 21, 2026
• Study Completion: April 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)