BruxismNCT05416788
Effect of Cervical Manipulation on Mouth Opening
A study testing cervical manipulation in people with Bruxism and Face Pain, run by University of Americas - Chili at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- cervical manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 11 May 2022to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de las Americas
Santiago, Santiago Metropolitan, 7750495
About this study
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.
- Being tested
- cervical manipulation, Sham intervention
- Medical subject headings
- Bruxism, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical manipulationOther
high-velocity, low-amplitude cervical manipulation
Sham interventionOther
lateral flexion and cervical rotation without manipulation
| Study group | Role | What they receive |
|---|---|---|
| Cervical manipulation group | Experimental | high-velocity, low-amplitude cervical manipulation Receives: Other: cervical manipulation |
| Control group | Sham comparator | placebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump Receives: Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal mouth opening in millimeters
With a buccal goniometer, the maximum mouth opening will be measured in millimeters.
Measured: Change from Baseline mouth open at 5 minutes
Secondary outcomes (1)
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.
Measured: Change from Baseline pain points at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start11 May 2022
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Astudillo Ganora, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416788
- Sponsor's protocol ID
- 60/2022
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Manipulation on Mouth Opening
- ClinicalTrials.gov ID
- NCT05416788
- Acronym / sponsor ID
- 60/2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical manipulation group | Experimental | Other: cervical manipulationhigh-velocity, low-amplitude cervical manipulation |
| Control group | Sham comparator | Other: Sham interventionplacebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical manipulationhigh-velocity, low-amplitude cervical manipulation | Other | Cervical manipulation group |
| Sham interventionlateral flexion and cervical rotation without manipulation | Other | Control group |
Primary outcome
normal mouth opening in millimeters
Time frame: Change from Baseline mouth open at 5 minutes
With a buccal goniometer, the maximum mouth opening will be measured in millimeters.
1 secondary outcome
masseter muscle pressure points
Time frame: Change from Baseline pain points at 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical manipulation in people with Bruxism and Face Pain, run by University of Americas - Chili at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal mouth opening in millimeters (time frame: Change from Baseline mouth open at 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.