Effect of Intraoral Mandibular Advancement Intraoral Appliance (OAm) therapy on Obstructive Sleep Apnea, systemic status, periodontium of pregnant women and its influence on the fetus and newborn: clinical-laboratory analysis of medical and dental images

Effect of the Intraoral Mandibular Advancement Device (AIOam) and the Silicone Occlusal Splint (POs) in pregnant women with Obstructive Sleep Apnea and on fetal growth: clinical-laboratory and medical-dental imaging analyses

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-7mmkzt7

Enrollment

Registered

2026-02-09

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

gestational hypertension

Interventions

This randomized controlled clinical study will investigate the effectiveness of the mandibular advancement oral appliance defined by efficacy associated with adherence in the treatment of obstructive

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Chronic hypertensive pregnant women with OSA (Apnea-Hypopnea Index AHI > 5 and < 30 events/hour); chronic hypertensive pregnant women with 20 to 22 weeks of gestation; oxyhemoglobin desaturation index (ODI) = 5 events/hour; chronic hypertensive pregnant women aged 20 to 35 years; chronic hypertensive pregnant women with healthy periodontium and absence of caries; nulliparous and multiparous chronic hypertensive pregnant women; sign the Free and Informed Consent Form

Exclusion criteria

Exclusion criteria: Women with pregnancy period < 20 weeks and > 22 weeks with apnea hypopnea index >30/h; with dessaturation index >30/h or with more than 10% of desaturation time <90%; active periodontal disease; severe temporomandibular disorder; drink alcohol; smoke and use drugs; use anti-inflammatory drugs; hormonal therapy; psychiatric disorders; infectious diseases; hematological diseases; clinical history of using orthodontic appliances less than 6 months before the proposed study; twin pregnancies; using antidepressants; using in vitro fertilization

Design outcomes

Primary

Measure	Time frame
We expect the reduction in 50% of the severity of obstructive sleep apnea in pregnancy by means of mandibular advancement oral appliance usage, confirmed by polysomnograpy exam	—

Secondary

Measure	Time frame
Authors expect the treatment may reduce systemic arterial hypertension by means of mandibular advancement oral appliance usage;Authors expect that new born present Apgar Scale with body lenght and weight with normal values by means of mandibular advancement oral appliance usage	—

Countries

Brazil

Contacts

Public ContactMonica Gomes

Instituto de Ciências eTecnologia ICT - Universidade Estadual Paulista Julio de Mesquita Filho - UNESP

monica.gomes@unesp.br+55 (12) 39479078

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026