Temporomandibular DisordersDeprogrammerNCT03180671
Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension
A study testing Deprogramer Sliding Guide, Deprogrammer Dawson B-Splint and Deprogrammer Kois in people with Temporomandibular Disorders, run by Lukasz Adamczyk at 1 site in Poland.
Trial summary
The study will be conducted in four groups of 20 patients in age of 20-30 years with complete dentition or single tooth loss in lateral regions, with masticatory muscle pain in the history or during examination and overuse and/or chronic tensing of the masticatory muscles. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Deprogramer Sliding Guide, Deprogrammer Dawson B-Splint and Deprogrammer Kois
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2017to 1 May 2019
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 20-30 years old
- complete dentition or single tooth loss in the lateral regions
- no severe systemic diseases
- masticatory muscle pain in the history or during examination
- increased masticatory muscles tension
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Dental Practice
Tarnów, 33-100
Lukasz Adamczyk, DMD, 48511230863, lukasz-stom@outlook.com
About this study
Official title: The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension
The study will be conducted in four groups of 20 patients in age of 20-30 years with complete dentition or single tooth loss in lateral regions, with masticatory muscle pain in the history or during examination and overuse and/or chronic tensing of the masticatory muscles. Patients will be randomly assigned to the groups.
Each person will be measured twice before and after use of selected anterior deprogrammer. The following assessment tools will be applied:
Read more
- surface electromyography of masseter and temporal muscles,
- intraoral pin-supported registration to draw a gothic arch.
Measurements will be made before and after intervention to assess the effect of anterior deprogrammer application on the tone of the selected masticatory muscles and condyles position in mandibular fossa. The first group (control) will be counsel with an explanation of the pathomechanism of masticatory muscles pain and preventive principles. In the second group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and 4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and eating/drinking.
The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.
- Conditions
- Temporomandibular Disorders
- Being tested
- Deprogramer Sliding Guide, Deprogrammer Dawson B-Splint, Deprogrammer Kois
- Keywords
- anterior deprogrammer, muscle pain, centric relation
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprogramer Sliding GuideDevice
Also called Occlusal splint
Use of the intraoral device.
Deprogrammer Dawson B-SplintDevice
Also called Occlusal splint
Use of the intraoral device.
Deprogrammer KoisDevice
Also called Occlusal splint
Use of the intraoral device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Control | No intervention | Counselling with explanation of preventive procedures. |
| Group 2 deprogramer Sliding Guide | Active comparator | Intervention using the Deprogrammer Sliding Guide for 12-15 minutes. Receives: Device: Deprogramer Sliding Guide |
| Group 3 deprogrammer Dawson B-Splint | Active comparator | Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures. Receives: Device: Deprogrammer Dawson B-Splint |
| Group 4 deprogrammer Kois | Active comparator | Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures. Receives: Device: Deprogrammer Kois |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
Examination of masseters and temporal muscles tension
Measured: 2 min
Secondary outcomes (1)
Centric relation
Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Apr 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lukasz Adamczyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lukasz Adamczyk, Wroclaw Medical University
- Investigators
- Mieszko Wieckiewicz, DMD, MSc, PhD, Study chair, Wroclaw Medical UniversityLukasz Adamczyk, DMD, Principal investigator, Dental Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180671
- Sponsor's protocol ID
- Anterior Deprogrammers
- Acronym
- Deprogrammer
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension
- ClinicalTrials.gov ID
- NCT03180671
- Acronym / sponsor ID
- Deprogrammer / Anterior Deprogrammers
- Conditions
- Temporomandibular Disorders
- Keywords
- anterior deprogrammer, muscle pain, centric relation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lukasz AdamczykUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 8 Jun 2017 (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.
The study will be conducted in four groups of 20 patients in age of 20-30 years with complete dentition or single tooth loss in lateral regions, with masticatory muscle pain in the history or during examination and overuse and/or chronic tensing of the masticatory muscles. Patients will be randomly assigned to the groups.
Each person will be measured twice before and after use of selected anterior deprogrammer. The following assessment tools will be applied:
- surface electromyography of masseter and temporal muscles,
- intraoral pin-supported registration to draw a gothic arch.
Measurements will be made before and after intervention to assess the effect of anterior deprogrammer application on the tone of the selected masticatory muscles and condyles position in mandibular fossa. The first group (control) will be counsel with an explanation of the pathomechanism of masticatory muscles pain and preventive principles. In the second group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and 4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and eating/drinking.
The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Control | No intervention | –Counselling with explanation of preventive procedures. |
| Group 2 deprogramer Sliding Guide | Active comparator | Device: Deprogramer Sliding GuideIntervention using the Deprogrammer Sliding Guide for 12-15 minutes. |
| Group 3 deprogrammer Dawson B-Splint | Active comparator | Device: Deprogrammer Dawson B-SplintIntervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures. |
| Group 4 deprogrammer Kois | Active comparator | Device: Deprogrammer KoisIntervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 20-30 years old
- complete dentition or single tooth loss in the lateral regions
- no severe systemic diseases
- masticatory muscle pain in the history or during examination
- increased masticatory muscles tension
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Deprogramer Sliding GuideAlso: Occlusal splintUse of the intraoral device. | Device | Group 2 deprogramer Sliding Guide |
| Deprogrammer Dawson B-SplintAlso: Occlusal splintUse of the intraoral device. | Device | Group 3 deprogrammer Dawson B-Splint |
| Deprogrammer KoisAlso: Occlusal splintUse of the intraoral device. | Device | Group 4 deprogrammer Kois |
Primary outcome
Electromyography
Time frame: 2 min
Examination of masseters and temporal muscles tension
1 secondary outcome
Centric relation
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- 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.
Mieszko Wieckiewicz, DMD, MSc, PhD study chair
Wroclaw Medical University
Lukasz Adamczyk, DMD principal investigator
Dental Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprogramer Sliding Guide, Deprogrammer Dawson B-Splint and Deprogrammer Kois in people with Temporomandibular Disorders, run by Lukasz Adamczyk at 1 site in Poland.
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 0 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. 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 Poland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mieszko Wieckiewicz, DMD, MSc, PhD (48660478759, m.wieckiewicz@onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 2 min). 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 8 Jun 2017.