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NCT05416788 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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. ยท 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)

Study Design

Related Conditions & MeSH terms

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
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