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Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04948541
Enrollment
40
Registered
2021-07-02
Start date
2021-04-21
Completion date
2021-07-15
Last updated
2026-03-18

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

Conditions

Pain, Pain, Face, Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Temporomandibular Disorder

Keywords

pain, sleep apnea, temporo-mandibular disorders

Brief summary

Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects. 41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.

Detailed description

Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects. 41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.

Interventions

COMBINATION_PRODUCTosa treatment

different treatments can be included

OTHERno treatment

no treatment was undergone

Sponsors

Anna Alessandri Bonetti
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment

Exclusion criteria

* patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination * patients presenting dental problems * patients assuming medications that would alter pain perception * patients not signing the informed consent

Design outcomes

Primary

MeasureTime frameDescription
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorderschange from baseline temporo-mandibular disorders at 18 monthsprevalence described as percentage of people having the disease

Secondary

MeasureTime frameDescription
change in TMD signs according to diagnostic criteria for temporo-mandibular disorderchange from baseline temporo-mandibular disorder signs at 18 monthsreduction described as percentage of people resolving the disease
change in TMD symptoms according to diagnostic criteria for temporo-mandibular disorderchange from baseline temporo-mandibular disorder symptoms at 18 monthsreduction in pain described by patients through a numeric rating scale going from 0 to 10, were 0 is no pain and 10 is the worst immaginabile pain

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026