Temporomandibular Joint DisorderPhase 2NCT02794922

Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

A Phase 2 study testing Neurovit Forte and Corn Starch in people with Temporomandibular Joint Disorder, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Temporomandibular Joint Disorder
What is being tested?: Neurovit Forte and Corn Starch
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteChina
Study dates: Sep 2015to Jul 2017
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

minimum age of 18
temporomandibular joint disorder with pain
chronic condition- symptoms lasting more than 3 months with at least 2 episodes of pain in last 1 month
language competence- in Cantonese or English
all ethnicity

Who cannot join

ankylosis of the joint
limited mental capacity
pregnancy and lactating mothers
inability to take medications (NSAIDS-Ibuprofen or Vitamin B)
undergoing concurrent pharmacotherapy with anti inflammatory or muscle relaxant medications
poor general health
history of TMJ trauma or TMJ surgery
subjects taking Vitamin B for other uses

Trial locations and contacts

1 site in 1 country.

China1 site

Prince Philip Dental Hospital
Hong Kong

Other trials in China

About this study

The purpose of this study is to determine effectiveness of vitamin B in reducing temporomandibular joint disorder (TMD) pain. Patients will be randomised to receive the study drug or placebo. The study drug we are using is a combination of vitamin B1(thiamine mononitrate)-242.5mg; vitamin B6(pyridoxineHCl)-250mg, and vitamin B12(cyanocobalamin)-1mg. We will assess patient's pain level, range of jaw movement and record any side effects from using this medication.

Read the detailed description

Type of study : Prospective double blinded randomized control trial Sample population : patients with temporomandibular joint disorder pain who are currently undergoing treatment in Oral \& Maxillofacial surgery unit, Prince Philip Dental Hospital Study Period : 2 year (1st may2015 to 1st may 2017)

Data Collection All new cases or existing TMD patients treated in oral maxillofacial surgery department, Prince Philip Dental Hospital will be acquired and screened based on inclusion and exclusion criteria. Selected patients will be categorised based on TMD axis 1 diagnosis and divided into two groups - group 1(Vitamin B) and group 2(placebo) randomly . Allocation of patients into the group will be based on computer generated by random block sequence.

Complete social demographic background of the patient will recorded according to the following format age, gender, race, education, and job.

Clinical assessment will be done to check 1. Mouth opening 2. Lateral excursion (right and left) 3. Protrusion 4. Deviation of lower jaw on opening 5. Tenderness of muscle of mastication 6. Pain - based on 10cm visual analog score.

After initial assessments, patients will be started on either vitamin B complex or placebo based on their group.

Both group of patients will be also prescribed with Tab Ibuprofen 400mg to be taken during acute Temporomandibular joint (TMJ) pain symptoms.
These patients will be reviewed on week 0,2,4 and 6.
All the patients will be reviewed by blinded assessor. Each patient will be given a log book to document frequency of TMJ pain attack, maximum pain score on each attack and amount of analgesics (Ibuprofen 400mg tabs) taken.
Log book record will be checked on their review.
Amount of analgesics recorded in log book and compliance of Vitamin B or placebo will be cross checked with remaining tablet count.

Data Evaluation/ Statistical Analyses The statistical analysis of this study will use the standard version of Statistical Package for the Social Sciences (SPSS) version 17.0 for windows. All the data will be gathered and entered in into this software.

Conditions: Temporomandibular Joint Disorder
Being tested: Neurovit Forte, Corn Starch
Keywords: Vitamin B, Temporomandibular joint disorder, trpv1
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurovit ForteDrug
Also called Vitamin B Complex
Corn StarchDrug

Study groups in NCT02794922
Study group	Role	What they receive
Interventional	Experimental	Name: Neurovit Forte tab Dosage: Each tablet contains Vitamin B1 242.5mg, Vitamin B6 250mg, Vitamin B12 1mg Frequency: One tab, once per day Duration: 6 weeks Receives: Drug: Neurovit Forte
Placebo	Placebo comparator	Capsule containing 250mg corn starch Receives: Drug: Corn Starch

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale(VAS) Pain Score
assessment of pain level with VAS score at baseline (week 0)
Measured: baseline
Visual Analog Scale(VAS) Pain Score
assessment of pain level with VAS score at week2
Measured: week 2
Visual Analog Scale(VAS) Pain Score
assessment of pain level with VAS score at week4
Measured: week 4
Visual Analog Scale(VAS) Pain Score
assessment of pain level with VAS score at week6
Measured: week 6

Secondary outcomes (6)

mouth opening measurement in millimeter (mm)
assessment of mouth opening in millimeter (mm) at baseline (week0)
Measured: baseline
mouth opening measurement in millimeter (mm)
assessment of mouth opening in millimeter (mm) at week 2
Measured: week 2
mouth opening measurement in millimeter (mm)
assessment of mouth opening in millimeter (mm) at week 4
Measured: week4
mouth opening measurement in millimeter (mm)
assessment of mouth opening in millimeter (mm) at week 6
Measured: week 6
number of participants with treatment related adverse events as assessed by CTCAE v4.03
Subjects will be assessed for any adverse events related to intervention , by using CYCAE v4.03, at week 0, week 2, week 4 and week 6
Measured: 6 weeks
tablet count measurements to check complaince
remaining tablets will be counted at end of Week 6 to check compliance rate towards treatment
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jul 2017

First posted9 Jun 2016 (estimated)
Study startSep 2015
Primary completionJun 2016
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Temporomandibular Joint DisorderStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02794922
Sponsor's protocol ID: UW 15 - 266
Status last verified: May 2018
First submitted: 30 May 2016
Last updated: 4 May 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Joint Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
ClinicalTrials.gov ID: NCT02794922
Acronym / sponsor ID: UW 15 - 266
Conditions: Temporomandibular Joint Disorder
Keywords: Vitamin B, Temporomandibular joint disorder, trpv1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: Sep 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jul 2017 (actual)
First posted: 9 Jun 2016 (estimated)
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.

Detailed description

Complete social demographic background of the patient will recorded according to the following format age, gender, race, education, and job.

After initial assessments, patients will be started on either vitamin B complex or placebo based on their group.

Both group of patients will be also prescribed with Tab Ibuprofen 400mg to be taken during acute Temporomandibular joint (TMJ) pain symptoms.
These patients will be reviewed on week 0,2,4 and 6.
All the patients will be reviewed by blinded assessor. Each patient will be given a log book to document frequency of TMJ pain attack, maximum pain score on each attack and amount of analgesics (Ibuprofen 400mg tabs) taken.
Log book record will be checked on their review.
Amount of analgesics recorded in log book and compliance of Vitamin B or placebo will be cross checked with remaining tablet count.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Interventional	Experimental	Drug: Neurovit ForteName: Neurovit Forte tab Dosage: Each tablet contains Vitamin B1 242.5mg, Vitamin B6 250mg, Vitamin B12 1mg Frequency: One tab, once per day Duration: 6 weeks
Placebo	Placebo comparator	Drug: Corn StarchCapsule containing 250mg corn starch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

minimum age of 18
temporomandibular joint disorder with pain
chronic condition- symptoms lasting more than 3 months with at least 2 episodes of pain in last 1 month
language competence- in Cantonese or English
all ethnicity

Key exclusion criteria (8 listed)

ankylosis of the joint
limited mental capacity
pregnancy and lactating mothers
inability to take medications (NSAIDS-Ibuprofen or Vitamin B)
undergoing concurrent pharmacotherapy with anti inflammatory or muscle relaxant medications

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
Neurovit ForteAlso: Vitamin B Complex	Drug	Interventional
Corn Starch	Drug	Placebo

Primary outcome

Visual Analog Scale(VAS) Pain Score
Time frame: baseline
assessment of pain level with VAS score at baseline (week 0)
Visual Analog Scale(VAS) Pain Score
Time frame: week 2
assessment of pain level with VAS score at week2
Visual Analog Scale(VAS) Pain Score
Time frame: week 4
assessment of pain level with VAS score at week4
Visual Analog Scale(VAS) Pain Score
Time frame: week 6
assessment of pain level with VAS score at week6

6 secondary outcomes

mouth opening measurement in millimeter (mm)
Time frame: baseline
mouth opening measurement in millimeter (mm)
Time frame: week 2
mouth opening measurement in millimeter (mm)
Time frame: week4
mouth opening measurement in millimeter (mm)
Time frame: week 6
number of participants with treatment related adverse events as assessed by CTCAE v4.03
Time frame: 6 weeks
tablet count measurements to check complaince
Time frame: 6 weeks

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 4 May 2018.

Related trials for Temporomandibular Joint Disorder

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

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.

Winnie Wing Shan Choi, BDS, MDS study director

Faculty of Dentistry, The University of Hong Kong

Jothi R Rajaran, DDS principal investigator

Faculty of Dentistry, The University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neurovit Forte and Corn Starch in people with Temporomandibular Joint Disorder, run by The University of Hong Kong at 1 site in China.

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 8 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 4 May 2018. 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 China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual Analog Scale(VAS) Pain Score (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02794922.

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 4 May 2018.