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Clinical Trials/NL-OMON45006
NL-OMON45006
Withdrawn
Not Applicable

Mandibular Advancement Device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant fixed MADs vs. CPAP. - MADE-study

Academisch Medisch Centrum0 sites38 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Academisch Medisch Centrum
Enrollment
38
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Male of female
  • •\- Age 18 \* 75 years
  • •\- Sufficient understanding of Dutch language in speaking and writing.
  • •\- Completely (mandibular and maxillary) edentate with or without dental implants
  • •\- Diagnosed with mild or moderate OSA (AHI between 5 \* 30\)
  • •\- No previous OSA therapy

Exclusion Criteria

  • •\- Craniofacial deformities
  • •\- Medication use related to a sleeping disorder
  • •\- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
  • •\- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
  • •\- Temporomandibular disorders
  • •\- Intravenous bisphosphonates therapy (osteoporosis).
  • •\- Previous radiotherapy in head and/or neck area

Outcomes

Primary Outcomes

Not specified

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