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Completed

NCT Number: NCT06188897

Biomechanical Relationship Between Trunk Flexion and Mouth Opening: Pilot Study

The aim of the present study is to analyze if there is a biomechanical relationship between trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion by performing the "sit and reach" test when stretching the masticatory muscles.

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Key information

Conditions

Hamstring Injury Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Stretch Temporomandibular Joint Disorders

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Menés Fernández

Vilanova i la Geltrú, Barcelona, 08800, Spain

About this study

The study design is made up of a double-blind clinical trial with 60 participants randomly divided into two groups of 30 people each (Treatment group and Control group). Basal measurements of the mouth opening were taken with a vernier caliper and the trunk flexion measurements were taken by means of the "sit and reach" test. These measurements were carried out again after the intervention, which consisted of self-stretching of the masticatory muscles for the Treatment group and an occlusion of the mouth for the Control group. In the results there was an increase in the trunk flexion compared to the initial values in both groups (Treatment group 2.8 (1.51), Control group 1.97 (2.31) and this increase was greater in the Treatment group even though the difference with the Control group was not statistically significant. Therefore, the stretching of the masticatory muscles does not cause an immediate increase in the degree of trunk flexion measured by the "sit and reach" test. As a consequence, we cannot confirm the existence of a biomechanical relationship between trunk flexion and mouth opening.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being between 18 and 26 years old (both included).
  • Having signed the consent form.
  • Being able to introduce three knuckles of the non-dominant hand between the incisors.

Exclusion criteria

  • Having a musculoskeletal injury in the lower extremity and / or in the jaw.
  • Being in the process of receiving physiotherapy treatment and / or having undergone any odontologic or maxillofacial surgery in the last month.
  • Having suffered dislocations, painful clicks or being diagnosed with some type of temporomandibular joint (TMJ) dysfunction.
  • Having hypermobility in the temporomandibular joint (TMJ) that is, the measurement of the buccal opening being greater than 60 mm.

Treatment and study plan

Self-stretching of the masticatory musculature

Other

If the subject belonged to the Treatment group, he was instructed to self-stretch the masticatory muscle.

This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting.

Control group intervention

Other

The control group was asked to introduce only two knuckles in the oral cavity and perform a mandibular occlusion, an intervention that serves as a simulated stretch in said group.

Primary outcomes

  1. Trunk flexion

    Time frame: 1 year

    Trunk flexion in cm, taken by using the "sit and reach" drawer (Eve-que). The measurements were made three consecutive times with an interval of five seconds between them. The result of the arithmetic average of the three measurements was the one that was accounted for in the study. For the measurement of trunk flexion, the subject was placed on the floor with his back against the wall and having the soles of both feet in contact with the drawer.

Secondary outcomes

  1. Mandibular opening

    Time frame: 1 year

    Mandibular opening in mm., assessed using the vernier caliper (INCUTEX Germany GmbHl). The measurement was made three consecutive times with an interval of five seconds between them. The result of the arithmetic average of the three measurements was the one that was caliper (corresponding to 0 of the ruler) was placed at the upper end of the lower central incisors and measured to the edge of the corresponding central incisor.

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Acronym: REFEM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

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.

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