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

Launched by UNIVERSITY OF KRAGUJEVAC · Feb 18, 2025

Keywords

ClinConnect Summary

BACKGROUND AND SIGNIFICANCE Fixed prosthetic appliances can pose a challenge to maintaining oral hygiene. The placement of fixed orthodontic appliances, for example, can compromise the patient's oral environment through the presence of additional surfaces and impeding oral hygiene procedures, which can affect the oral microbiota balance. Rough and irregular margins on the fixed prosthetic constructions can also result in microorganisms' attachment, which can worsen oral hygiene conditions and cause gingivitis and further periodontitis .

Oral hygiene practices include brushing with fluoride...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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