Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy

Obstructive sleep apnea (OSA) is a major medical problem, estimated to affect
up to 15-30% of the adults in the USA. Characterized by repetitive obstructions
of the upper airway during sleep, OSA results in fragmented sleep and excessive
daytime sleepiness. Consequences of untreated OSA are serious and include
cardio- and cerebrovascular disease, diabetes mellitus, depression, glaucoma
and increased all-cause mortality. It is also related to an increased risk of
involvement in motor vehicle crashes and a decreased quality of life (QoL).
Major risk factors for OSA include male gender, higher age, obesity, smoking
and craniofacial abnormalities. In the Netherlands approximately 41 percent of
the individuals older than 65 years are completely edentulous. As a result of
morphological changes, a higher incidence of OSA is reported in (partial)
edentate individuals compared to the general population. The exact prevalence
of edentulousness in OSA patients is unknown, however this number is likely to
be significant and increasing due to the aging population and current rise of
obesity. Continuous positive airway pressure (CPAP) therapy is the current gold
standard in OSA therapy next to lifestyle alterations. Although CPAP therapy is
widely used in OSA management, it is accompanied with high non-adherence rates
up to 80% due to side effects and wearing discomfort. Oral appliance therapy
(e.g. mandibular advancement device therapy) is a viable and effective
treatment alternative, however requires sufficient dentition for device
retention. This results in oral appliance therapy not being usable in up to one
third of all OSA patients due to dental limitations. Due to the low CPAP
compliance rates, the potential risks of untreated OSA and the lack of other
suitable therapies there is an unmet clinical need of effective treatment
strategies for edentulous OSA patients. Very limited evidence is available
regarding the outcomes of treatment with MADs or CPAP in edentulous OSA
patients. Some case studies showed the potential effectiveness of dental
implant retained mandibular advancement device (MAD) therapy in edentulous OSA
patients, tackling the major obstacle of poor device retention. An MAD is an
intra-oral prosthesis which holds the mandible in a forced protrusive position
during sleep, resulting in an increased pharyngeal airway space. Implant
retained MADs could potentially tackle the problem of poor device retention in
edentulous OSA patients and become a viable treatment option for these
patients. Our hypothesis is that MAD treatment retained on maxillary and
mandibular overdentures fixed with 2 mandibular dental implants and 4-6
optionally maxillary implants (based on most recent implantology guidelines
NVOI) is an effective treatment strategy in edentulous OSA patients in terms of
sleep apnea reduction, wearing comfort/side effects and compliance.

The main purpose of this pilot study is to assess the feasibility and potential
efficacy of implant retained mandibular advancement device (MAD) therapy on a
small scale in edentulous patients with mild to moderate OSA in terms of sleep
apnea reduction. Additionally the treatment will be evaluated in terms of
therapy compliance, side-effects, quality of life and complications (e.g.
hypertension, depression symptoms). The outcomes of this exploratory study can
be used for larger scale hypothesis testing clinical trials on implant retained
MAD therapy in edentulous OSA patients.

Non-randomized pilot study

Mandibular Advancement Device (MAD) therapy; MAD retained on upper and lower
overdentures fixed with 2 mandibular dental implants (or pre-existing dental
implants). In case of overdenture related complaints during the MAD treatment
work-up (e.g. retention problems), treatment can be upscaled with the placement
of 4-6 maxillary implants placement (if absent before treatment) to improve
retention as part of the regular implant retained overdenture treatment
protocol (NVOI Implantology Guidelines 2015).

Both dental implant retained overdentures and MAD-treatment are
well-established treatment that are widely used in daily clinical practice.
Burden and risks associated with participation in this study are related to the
therapy. General (potential) side effects of MAD therapy include discomfort of
the jaw, sensitivity of the maxilla and a dry mouth. Termination of the MAD use
would result in quick relief of the above mentioned symptoms. Dental implant
placement (if required) is a routine surgical procedure. All patients
undergoing such a procedure are at risk for the general complications
associated with dental implants, comprising of infection (peri-implantitis) and
bleeding related to the procedure. In case of such events, patients might
require additional treatment.