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Treatment of Sleep Apnea with Innovative Intraoral Appliance Customized by Digital Flow

Comparison of CPAP and Intraoral Aplliance for the Treatment of Obstrutive Sleep Apnea - CPAP - Continuous Positive Airway Pressure The trial scientific acronym expansion CPAP is "Continuos Positive Airway Pressure".

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3m46ncg
Enrollment
Unknown
Registered
2024-03-21
Start date
2023-10-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Interventions

The research is a crossover study to evaluate an innovative mandibular advancement device manufactured by digital flow in Dentistry for the treatment of obstructive sleep apnea. This study will be car
with the use of Continuous Positive Airway Pressure and with the use of an intraoral appliance for mandibular advancement during sleep. Mandibular advancement or titration will be performed progressi

Sponsors

Universidade de Brasília - Faculdade de Ciências da Saúde
Lead Sponsor
Clínica Faber Hospital Odontológico LTDA
Collaborator

Eligibility

Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria in the treatment group are individuals diagnosed with mild apnea (apnea-hipopnea index bigger than five and smaller than fifteen), moderate apnea (apnea-hipopnea index bigger than fifteen and smaller than thirty) and severe apnea (apnea-hipopnea index bigger than thirty and smaller than fifty) by type I polysomnography; individuals who used Continuous Positive Airway Pressure and did not adapt or just want an alternative to this type of treatment; individuals who refused surgical treatment; individuals with age between forty and seventy years of both genres; individuals with at least ten teeth per arch, including crowns on implants or complete dentures over implants

Exclusion criteria

Exclusion criteria: The exclusion criterias of the treatment group are patients who are edentulous or do not have a minimum amount of teeth per arch necessary for the retention and stability of the intraoral appliance during treatment; patients with severe periodontal disease; patients with acute temporomandibular disorder; patients with pathological evidence of airway obstruction; pacientes with Body Mass Index (BMI = weight/height2) greater than thirty five

Design outcomes

Primary

MeasureTime frame
Evaluate the effectiveness of the mandibular advancement device in reducing the oxygen desaturation rate and snoring.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactTaciana Morum

Universidade de Brasília - Faculdade de Ciências da Saúde

taciana110@hotmail.com+55(61)981915288

Outcome results

None listed

Source: REBEC (via WHO ICTRP)