Efficacy and Safety of the "Neo Pill" Device for Keeping Oral Hygiene in Patients with Fixed Orthodontic Appliance

NCT06834139 | Enrolling By Invitation

• 1 other identifier: 01-3909
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Orthodontic appliances interfere with oral hygiene and contribute to plaque retention, gingival inflammation and demineralization of enamel. Current techniques for keeping oral hygiene (teeth brushing, rinsing oral cavity with 0.12% chlorhexidine, dental floss, interdental brush, Miswak) are not sufficiently effective (1). Up to 78% of patients do not follow instructions to keep oral hygiene with current methods which require discipline and effort (2). There is great need for some simple medical device to keep oral hygiene in an effective, safe and easy-to-use way. Objective: To evaluate efficacy and safety of NeoPill electrolysis device for keeping oral hygiene in patients with fixed orthodontic appliances. Hypotheses: (1) NeoPill electrolysis device in addition to standard oral hygiene techniques improves values of oral health indices (gingival bleeding index, papillary bleeding index, plaque index, and ortho-plaque index) and is associated with fewer white spots on enamel during and after 6 months of use in comparison to standard oral hygiene techniques only; (2) the adverse event rates in patients using the NeoPill electrolysis device and in patients keeping oral hygiene only with standard techniques is not significantly different; (3) quality of life in patients using the NeoPill electrolysis device is higher than in patients keeping oral hygiene only with standard techniques. Methods: The study is designed as prospective cohort investigation. Primary outcomes of the study are: the Turesky Modified Quigley Hein Plaque Index (TQHPI) for both anterior and posterior teeth Gingival Inflammation Score (GIS) for both anterior and posterior teeth, Papillary bleeding index (PBI), Ortho-Plaque Index (OPI), number of white spots on enamel, and safety (incidence of adverse events). Secondary outcomes are quality of life and overall costs of keeping oral hygiene. Main independent variable in the study is administration of the NeoPill electrolysis device produced by start-up innovative company Laviefarm, Belgrade, Serbia. The device causes detachment of bacteria from fixed orthodontic appliances and teeth, which are then washed out with mouth rinse, and swallowed or spitted out. Implications and significance: If proved effecive and safe, the NeoPill electrolysis device will make major contribution to improvement of oral hygiene in patients with fixed orthodontic appliances.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (6)

• 1. The Turesky Modified Quigley Hein Plaque Index (TQHPI) for both anterior and posterior teeth

  This is the scale (questionnaire), unit of measurement is the score of the scale.

  6 months

• 2. Gingival Inflammation Score (GIS) for both anterior and posterior teeth

  This is the scale (questionnaire), unit of measurement is the score of the scale.

  6 months

• Papillary bleeding index (PBI)

  This is the scale (questionnaire), unit of measurement is the score of the scale.

  6 months

• Ortho plaque index

  This is the scale (questionnaire), unit of measurement is the score of the scale.

  6 months

• Number of white spots on enamel

  It is measured by direct observation of the teeth; the unit of measurement is number of white spots.

  6 months

• Safety (incidence of adverse events)

  Adverse events are recorded by direct observation and interview with the patients. Unit of measurement is number of adverse events.

  6 months

Secondary Outcomes (1)

• Costs of treatment

  6 months

Study Arms (2)

Neo Pill group

The Neo Pill group include patients with fixed orthodontic appliance who will use Neo Pill device for improving oral hygiene.

Control group

The Control group will include patients with fixed orthodontic appliance who will not use Neo Pill device, but will keep oral hygiene in conventional way (toothbrush, etc.)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Fixed orthodontic appliance in place

You may qualify if:

• Provision of signed and dated informed consent form
• Fixed orthodontic appliance in place for at least 15 days
• Aged 18 years or above
• Good general health
• Permanent dentition
• Less than 5 mm of anterior crowding or spacing with adequate overjet and overbite
• Ability to maintain adequate oral hygiene
• Optimum dental health without immediate need for any allied dental procedure

You may not qualify if:

• Pregnancy, anticipated pregnancy, or breastfeeding
• Incarceration or institutionalized living
• Participation in another clinical study
• Life expectancy \<4 months
• Patients with moderate to severe renal insufficiency (acute or chronic) with glomerular filtration rate of less than 30 ml/min
• Patients with active bronchospastic disorders
• Heart failure classes III and IV
• Active dental caries
• Active periodontal disease
• Chronic systemic diseases
• Using antibiotics within the last 30 days
• Skeletal anteroposterior discrepancies between the maxilla and the mandible (ANB equal or above 5 degrees)
• Centric relation-centric occlusion discrepancies greater than 3 mm
• Patients with pace-makers and other implanted devices that require stable supply by electric energy

Sponsors & Collaborators

• University of Kragujevac: lead

Study Sites (1)

University of Kragujevac, Faculty of Medical Sciences

Kragujevac, Serbia, 34000, Serbia

Location

Study Officials

• Slobodan Janković, DSc, MD

  University of Kragujevac, Faculty of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)