Effect of Cervical Manipulation on Mouth Opening

Bruxism Clinical Trial

Official title:

Effect of Cervical Manipulation on Mouth Opening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416788
• Other study ID #: 60/2022
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: May 11, 2022

Study information

• Verified date: June 2022
• Source: University of Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: To compare the effects of cervical manipulation on the ranges of motion of

mouth opening and painful pressure points in the masseter and temporal muscles after

of cervical manipulation compared to the control group.

Material and methods: Single-blind randomized clinical trial with two arms, one group

intervention and a control group.

Hypothesis: There is a significant difference in mouth opening and painful pressure points

between the intervention group and the control group.

Expected results: The intervention group would significantly increase their mouth opening

maximal and decrease pressure pain in the masseter and temporalis muscles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects over 18 years of age, men and women

• Students with neck and/or facial pain minimum 3/10 VAS scale

• Kinesiology students who regularly attend face-to-face classes

who have a mobility pass and a health declaration.

· Students who read and sign the informed consent.

Exclusion Criteria:

• Orthognathic surgery

• Head and neck fracture or injury

• Contraindication (red flag) to perform high-speed, low-amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)

• Positive cervical safety tests (example: Klein test positive)

Related Conditions & MeSH terms

• Bruxism
• Face Pain

Intervention

Other:
• cervical manipulation
high-velocity, low-amplitude cervical manipulation
• Sham intervention
lateral flexion and cervical rotation without manipulation

Locations

Country	Name	City	State
Chile	Universidad de las Americas	Santiago de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Americas

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal mouth opening in millimeters	With a buccal goniometer, the maximum mouth opening will be measured in millimeters.	Change from Baseline mouth open at 5 minutes
Secondary	masseter muscle pressure points	Pain points will be measured under pressure with a pressure pain meter or algo meter. This measurement will be measured in kilograms.	Change from Baseline pain points at 5 minutes