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The influence of the use of Removable Dental Prostheses on obstructive sleep apnea

Use of complete denture conventional bimaxillary during sleep and its influence in degree of apnea, quality of sleep, and life quality: blind randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2sz93ch
Enrollment
Unknown
Registered
2021-06-05
Start date
2020-10-03
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

obstructive sleep apnea

Interventions

Patients previously diagnosed with obstructive sleep apnea, belonging to the sleep and heart institute of the cardiology emergency room at the University of Pernambuco (PROCAPE), will be screened for
20 patients will have both arches rehabilitated.

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: complete edentulous bimaxillary adults; complete denture users; obstructive sleep apnea previously diagnosed by nocturnal polysomnography; presence of healthy mucous membranes; availability to attend the clinic during the intervention and data collection periods; sign a free and informed consent form.

Exclusion criteria

Exclusion criteria: participants who present xerostomia without treatment; history of radiotherapy in the head and neck region; need for pre-prosthetic surgery; smokers; who do not have the cognitive ability to answer the questionnaires; neuromuscular changes.

Design outcomes

Primary

MeasureTime frame
Verify whether the use of complete denture during sleep changes the degree of sleep apnea through the polysomnography exam, sleeping with the prostheses (CP) and 90 days without the prostheses (SP).

Secondary

MeasureTime frame
To assess whether sleep quality improves with the use of complete dentures using the Pittsburgh Sleep Quality Index (PSQI), Berlin questionnaire, and Epworth sleepiness scale (EES) in the two proposed times.;Check if there is an improvement in the quality of life of the rehabilitated participants using the OHIP-EDENT questionnaire, in the two proposed times.;To verify through computed tomography the influence of the use of complete dentures in the amplify/ volume of the pharyngeal space and changes in different anatomical structures, in the two proposed times.;Check if there is an improvement in the cardiovascular parameters by measuring blood pressure and heart rate, in the two proposed times. Assess the sociodemographic characteristics, systemic conditions, and oral health status of participants diagnosed with obstructive sleep apnea in the database of the sleep and heart institute.;Using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire, the participants' quality of life was evaluated.;To evaluate, through spirometry, the influence of the use of complete dentures on the parameters of forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), mean expiratory flow (FEF25-75%) and peak expiratory flow ( PEF/FEF), with the prostheses (CP) and without the prostheses (SP)

Countries

Brazil

Contacts

Public ContactSandra Lúcia Moraes

Universidade de Pernambuco

sandra.moraes@upe.br+5581988506972

Outcome results

None listed

Source: REBEC (via WHO ICTRP)