Myofacial Pain SyndromesNCT05959174
Evaluation of 3D Michigan Appliance
A study testing 3D printed mitchigen appliance and side chair appliance in people with Myofacial Pain Syndromes, run by Fayoum University at 1 site in Egypt.
Trial summary
20 patients will be divided into 2 groups Group 1 : in which conventional appliance will be constructed after alginate impression Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofacial Pain Syndromes
- What is being tested?
- 3D printed mitchigen appliance and side chair appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 30 May 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with bruxism
- Trigger points
- Medically stable
Who cannot join
- • absence of other TMJ problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Algorithm for 3d Printed Michigan Appliances in Patients With Temporomandibular Disorders
- 20 patients will be divided into 2 groups
- Group 1 : in which conventional appliance will be constructed after alginate impression
- Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning
- Conditions
- Myofacial Pain Syndromes
- Being tested
- 3D printed mitchigen appliance, side chair appliance
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed mitchigen applianceDevice
the process of appliance construction done by intra-oral scanning of the arch and 3d printing
side chair applianceDevice
the impresion will be taken to make a cast to reconstruct the appliance
| Study group | Role | What they receive |
|---|---|---|
| 3d printed appliance | Active comparator | Not described Receives: Device: 3D printed mitchigen appliance |
| side chair appliance | Active comparator | Not described Receives: Device: side chair appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
pain assessment by visual analog scale (0-10) as 0 means no pain and 10 means severe pain immediately postoperative and 6 months later
Measured: Change from immediate postoperative to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start15 Jun 2023
- Primary completion28 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofacial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959174
- Sponsor's protocol ID
- 3
- Status last verified
- Apr 2024
- First submitted
- 17 Jul 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shabaan AA, Ragab O, Ragab R, Sharshar H, Refahee SM. Fully digital workflow versus conventional methods for fabricating the Michigan appliance in patients with temporomandibular joint disorder. A randomized controlled clinical trial. BMC Oral Health. 2026 May 13;26(1):881. doi: 10.1186/s12903-026-08534-w.
PubMed 42121118
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Algorithm for 3d Printed Michigan Appliances in Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05959174
- Acronym / sponsor ID
- 3
- Conditions
- Myofacial Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 25 Jul 2023 (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.
- 20 patients will be divided into 2 groups
- Group 1 : in which conventional appliance will be constructed after alginate impression
- Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3d printed appliance | Active comparator | Device: 3D printed mitchigen appliance |
| side chair appliance | Active comparator | Device: side chair appliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with bruxism
- Trigger points
- Medically stable
Key exclusion criteria (1 listed)
- • absence of other TMJ problem
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 |
|---|---|---|
| 3D printed mitchigen appliancethe process of appliance construction done by intra-oral scanning of the arch and 3d printing | Device | 3d printed appliance |
| side chair appliancethe impresion will be taken to make a cast to reconstruct the appliance | Device | side chair appliance |
Primary outcome
visual analogue scale
Time frame: Change from immediate postoperative to 6 months
pain assessment by visual analog scale (0-10) as 0 means no pain and 10 means severe pain immediately postoperative and 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 42121118Shabaan AA, Ragab O, Ragab R, Sharshar H, Refahee SM. Fully digital workflow versus conventional methods for fabricating the Michigan appliance in patients with temporomandibular joint disorder. A randomized controlled clinical trial. BMC Oral Health. 2026 May 13;26(1):881. doi: 10.1186/s12903-026-08534-w.
- Individual participant dataSharing planned: Undecided
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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 3D printed mitchigen appliance and side chair appliance in people with Myofacial Pain Syndromes, run by Fayoum University at 1 site in Egypt.
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 3 inclusion and 1 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 17 Apr 2024. 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 Egypt. 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?
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 analogue scale (time frame: Change from immediate postoperative to 6 months). 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 NCT05959174, which also lists 1 linked publication.
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 17 Apr 2024.