NCT06188897

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1 day

First QC Date

December 18, 2023

Last Update Submit

January 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Trunk flexion

    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.

    1 year

Secondary Outcomes (1)

  • Mandibular opening

    1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group did the intervention, which consisted of self-stretching of the masticatory muscles. This stretch consisted of introducing three knuckles of the non-dominant hand between the incisors for two minutes while sitting

Other: Self-stretching of the masticatory musculature

Control group

PLACEBO COMPARATOR

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.

Other: Control group intervention

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Menés Fernández

Vilanova i la Geltrú, Barcelona, 08800, Spain

Location

Related Publications (2)

  • Espejo-Antunez L, Castro-Valenzuela E, Ribeiro F, Albornoz-Cabello M, Silva A, Rodriguez-Mansilla J. Immediate effects of hamstring stretching alone or combined with ischemic compression of the masseter muscle on hamstrings extensibility, active mouth opening and pain in athletes with temporomandibular dysfunction. J Bodyw Mov Ther. 2016 Jul;20(3):579-87. doi: 10.1016/j.jbmt.2015.12.012. Epub 2016 Jan 7.

    PMID: 27634081BACKGROUND
  • Rodriguez-Blanco C, Cocera-Morata FM, Heredia-Rizo AM, Ricard F, Almazan-Campos G, Oliva-Pascual-Vaca A. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study. J Altern Complement Med. 2015 Aug;21(8):451-9. doi: 10.1089/acm.2014.0332. Epub 2015 Jun 2.

    PMID: 26218883BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

February 1, 2023

Primary Completion

February 2, 2023

Study Completion

February 15, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations