ASSOCIATION BETWEEN TEMPOROMANDIBULAR D… | Clinical Trial

Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Sleep Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Hospital, Milan, Italy

About this study

Temporomandibular disorders (TMD) are complex conditions, which can have a significant impact on patients' health and quality of life. Furthermore, they are unclearly associated with sleep disorders. The aim of the study is to investigate the prevalence of TMD in patients with sleep disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 years
Famale and Male
Signature of the privacy information form
Signature of the informed consent form of the protocol
Subjects capable of understanding and wanting
Subjects suffering from a sleep disorder (Insomnia,Hypersomnia,Restless legs syndrome,REM sleep behavior disorder,Narcolepsy,Obstructive sleep apnea syndrome (OSAS),Primary snoring, REM parasomnias,Nocturnal epilepsy)

Exclusion criteria

Physical trauma to the head and neck area
Painful oral pathologies (e.g. pulpitis, tooth fractures, tooth abscesses, tooth decay, canker sores and mucosal wounds)
Recent dental treatments that may cause pain (e.g. tooth extraction, tooth root canal)
Use of oral contraceptives
Subjects not capable of understanding and wanting
Patients suffering from neurological pathologies that may interfere with the completion of the questionnaires (ES dementia) or psychiatric pathologies or drug use as per DSM-5 criteria (including schizophrenia, bipolar, major depression, substance abuse, personality disorders).

Treatment and study plan

Questionnaire and Physical Exam

Other

The diagnostic questionnaires will be administered and the participants' responses will subsequently be analyzed, evaluating the presence of temporomandibular disorders (DTMs) in patients with sleep disorders.

The questionnaires will be administered to patients with a previous diagnosis of sleep disorder carried out at a specialist centre, consecutively belonging to the outpatient clinics of both centers U.O of Neurology-Sleep Disorders Center and U.O of Dentistry.

Primary outcomes

Primary Outcome

Time frame: at enrollment
The main aim of the present study is to evaluate the prevalence of TMDs in patients with sleep disorders. This population was selected in order to contribute, in the context of scientific research, to the investigation into the association between temporomandibular disorders and sleep disorders, which include all those disorders that compromise both the quantity and quality of sleep with repercussions important on general health and quality of life, like:
- Insomnia
- Hypersomnia
- Restless legs syndrome
- REM sleep behavior disorder
- Narcolepsy
- Obstructive sleep apnea syndrome (OSAS)
- Primary snoring
- REM parasomnias (Sleepwalking, arousal disorders, excessive daytime sleepiness and night terrors)
- Nocturnal epilepsy Patients with sleep disorders may be recruited in the observational study conducted by the University's Department of Dentistry Vita-Salute San Raffaele and the Neurology-sleep disorders unit of the San Raffaele Hospital in Turro, aimed at evaluating the prevalence of T

Secondary outcomes

Secondary Outcome

Time frame: at enrollment

Through this study we also want to evaluate the difference between the prevalence of TMDs in patients with sleep disorders and the prevalence of TMDs in non-patological population through the data present in the scientific literature.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Ferini-Strambi, MD

CONTACT

[email protected]

+390226433363 ext. +39

Simona Tecco, MD

CONTACT

[email protected]

+390226432970 ext. +39

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: Gnathology TMD

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: May 16, 2025
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting