Muscle DisorderNCT06138535
Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder
A study testing digital stabilizing splint in people with Muscle Disorder, run by zahraa hassan at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are: is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Disorder
- What is being tested?
- digital stabilizing splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2022to 10 Nov 2023
- 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
- 1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria
- Absence of previous occlusal splint therapy.
- Absence of apparent dental or periodontal diseases.
- Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.
- Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.
- Patients with multiple teeth loss that affects occlusal splint support were excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:
- is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .
Read the detailed description
The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted.
- Conditions
- Muscle Disorder
- Being tested
- digital stabilizing splint
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital stabilizing splintDevice
Also called occlusal splint
3D Printed stabilizing splint that has been digitally designed on a modern software
| Study group | Role | What they receive |
|---|---|---|
| Masticatory Muscle Disorder patients treated by digital stabilizing splint | Other | digital stabilizing splint Receives: Device: digital stabilizing splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient questionnaire (clinical symptoms).
Patient questionnaire (clinical symptoms) . The questionnaire was used to detect the clinical symptoms scoring that ranges from 0 to 10 (10 being greatest pain/dysfunction and 0 signifying no pain/proper function).
The success or failure was determined by the reduction in pain and dysfunction postoperatively.
the scales were taken for all eight patients before and after 3 months of treatment.
the questionnaire included questions about different clinical symptoms as following: headaches, facial discomfort, jaw joint pain, pain during mastication, neck pain, difficulty opening the mouth, difficulty in jaw movements, complaints during chewing, and clenching habits.
Measured: 3 months
Secondary outcomes (1)
Clinical sign such as mouth opening
Clinical sign such as mouth opening that was recorded by measuring the distance between the upper and lower central incisors by a caliper in millimeters unit.
the increase in mouth opening indicates positive clinical improvement. the mouth opening was measured before and after 3 months of treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Sep 2022
- Primary completion30 Oct 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single arm group study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- zahraa hassan
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, zahraa hassan, Al-Azhar University
- Investigators
- zahraa hassan, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138535
- Sponsor's protocol ID
- AZJD-D-23-00044
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be obtained either from study investigators or via data-sharing repositories or platforms.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder
- ClinicalTrials.gov ID
- NCT06138535
- Acronym / sponsor ID
- AZJD-D-23-00044
- Conditions
- Muscle Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- zahraa hassanUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 18 Nov 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.
The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:
- is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .
Detailed description
The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm group study
| Arm | Type | Receives |
|---|---|---|
| Masticatory Muscle Disorder patients treated by digital stabilizing splint | Other | Device: digital stabilizing splintdigital stabilizing splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria
- Absence of previous occlusal splint therapy.
- Absence of apparent dental or periodontal diseases.
- Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.
- Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.
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 |
|---|---|---|
| digital stabilizing splintAlso: occlusal splint3D Printed stabilizing splint that has been digitally designed on a modern software | Device | Masticatory Muscle Disorder patients treated by digital stabilizing splint |
Primary outcome
Patient questionnaire (clinical symptoms).
Time frame: 3 months
Patient questionnaire (clinical symptoms) . The questionnaire was used to detect the clinical symptoms scoring that ranges from 0 to 10 (10 being greatest pain/dysfunction and 0 signifying no pain/proper function). The success or failure was determined by the reduction in pain and dysfunction postoperatively. the scales were taken for all eight patients before and after 3 months of treatment. the questionnaire included questions about different clinical symptoms as following: headaches, facial discomfort, jaw joint pain, pain during mastication, neck pain, difficulty opening the mouth, difficulty in jaw movements, complaints during chewing, and clenching habits.
1 secondary outcome
Clinical sign such as mouth opening
Time frame: 3 months
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 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data may be obtained either from study investigators or via data-sharing repositories or platforms.
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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.
zahraa hassan principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital stabilizing splint in people with Muscle Disorder, run by zahraa hassan 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 6 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
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?
Patient questionnaire (clinical symptoms). (time frame: 3 months). 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 18 Nov 2023.