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The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05783128
Enrollment
134
Registered
2023-03-24
Start date
2023-03-01
Completion date
2024-07-31
Last updated
2024-10-28

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

Conditions

Airway Management, Endotracheal Intubation, Regional Anesthesia, Supraglottic Airway Device

Keywords

Intubation, Laryngeal Masks, Temporomandibular Joint Disorders, Orofacial Pain

Brief summary

The manipulations required during airway management and the different methods of establishing an airway (endotracheal intubation, supraglottic airway device etc) during anesthesia, as well as certain drugs used during anesthesia and sedation, may have an impact to the stomatognathic system. These effects can vary from a subtle temporomandibular joint disc displacement with reduction to the onset of temporomandibular disorders to previously healthy subjects.This observational prospective study aims at investigating the effect of different methods of airway management during anesthesia on the stomatognathic system (including temporomandibular joint, mastication muscles, occlusion etc).

Detailed description

After being informed about the study, all patients giving written informed consent will undergo elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia. Participants will be assigned to groups, depending on the method of airway management during anesthesia (endotracheal intubation, supraglottic airway device, sontaneous breathing). Clinical examination of the stomatognathic system will be performed preoperatively and postoperatively (24 hours after surgery) and data concerning signs and symptoms associated with the development of temporomandibular disorders will be recorded. A follow-up questionnaire will be administered by telephone 30 days after surgery in order to record data concerning the stomatognathic system and mandibular function. Parameters related to the physiology of the stomatognathic system, parameters related to the airway management technique, patient position, parameters related to postoperative recovery, as well as postoperative analgesic consumption will be studied.

Interventions

OTHERAirway management techniques (exposure)

The exposure reffers to the different methods of airway management during general or regional anesthesia.

Sponsors

Aretaieio Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women * 18-70 years old * ASA I-III * elective abdominal surgery or elective gynecological surgery * general or regional anesthesia

Exclusion criteria

* edentulous patients * ear disease * history of head and/or neck cancer * head and neck surgery, surgery that is known to affect temporomandibular joints * nose and/or skull base fractures * history of dystonia/musculoskeletal disease that require treatment with muscle relaxant drugs * cognitive impairment * ASA \> 3 * patients which underwent over 3 attempts of airway establishment during airway management * change of anesthesia plan during surgery * patient refusal to participate * inability to comprehend Greek or English * patient participation in another research project during the previous 30 days

Design outcomes

Primary

MeasureTime frameDescription
Pain free maximum mouth opening24 hoursAssessment of maximum pain free inter-incisor distance (measured in millimeters). The examination will be conducted using the set of diagnostic tools for temporomandibular disorders (TMD), namely the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

Secondary

MeasureTime frameDescription
Range of movement of the temporomandibular joint24 hoursAssessement of forward and lateral movements of the jaw using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Temporomandibular joint disc displacement (with/without reduction)24 hoursAssessement of clicking of the jaw while opening/closing the mouth using DC/TMD
Articular sounds incidence24 hoursAssessement of grinding noises and nonclassifiable sounds using DC/TMD
Subjective limitation of jaw movement24 hoursAssessement of subjective report of jaw movement limitation using DC/TMD
Subjective report of orofacial pain24 hoursAssessement of subjective report of orofacial pain using DC/TMD

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026