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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Change in aerobic oral bacterial load [Срок оценки: Immediately before and immediately after the intervention (same study visit)]

Вторичные конечные точки (1)

• Participant-reported usability and comfort of the NeoPill device [Срок оценки: Immediately after device use (same study visit)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Cyprus · 1 центр

• German Medical Institute — Limassol

Идентификаторы

NCT: NCT07355400 · ЕЕВК/ЕП/2025/72

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗