utraceutical-based therapy in the management of disorders of the jaw joint and muscles that control jaw movement

Not Applicable

Completed

• Conditions: Temporomandibular joint disorders; Digestive System

• Registration Number: ISRCTN71924789
• Lead Sponsor: Sapienza University of Rome

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38958698/ (added 08/07/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-06-20
• Study Start: 2023-12-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

1. Presence of dysfunctions of the craniocervical musculature, in the presence or absence of parafunction
2. Presence of muscular pain at the level of the masseter of the medium-high entity with a minimum value of 40 and a maximum of 100 according to the VNS (verbal numerical scale), spontaneous and/or investigated by palpatory manoeuvres
3. Presence of arthralgia in at least one temporomandibular joint
4. Presence of the following comorbidities such as headache attributed to temporomandibular disorders, cervicalgia
5. Presence of sleep disturbances (no OSAS) and emotional factors (stress and anxiety) investigated with a nominal scale (presence or absence)
6. Patients waiting for or undergoing conservative gnathological therapy

Exclusion Criteria

1. Psychiatric pathologies
2. Systemic pathologies with disease-related muscular impairment
3. Pain therapy or myorelaxant medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of temporomandibular disorder pain measured using the Verbal Numerical Scale (VNS) at T0 ( before treatment) and T1 (after treatment)

Secondary Outcome Measures

Name	Time	Method
1. Improvement of quality of life relating to physical disabilities measured using the Verbal-Numerical Scale (VNS) to report the severity, if present, of comorbidities, such as headache and neck pain and presence/absence of sleep/emotional disturbances (only with a dichotomic classification yes/no) at T0 and T1<br>2. Analysis of mandibular function (presence of articular noises, evaluation of functional excursions and maximum mouth opening) and palpatory examination were also recorded at T0 and T1<br><br>