Temporomandibular Disorders (TMD)NCT06781138
Comparison Between Conventional Versus 3D-Designed and Printed Stabilization Splints for Treatment of TMD Patients: A Randomized Clinical Trial.
A study testing Conventional stabilization splint and 3D designed and printed stabilization splints in people with Temporomandibular Disorders (TMD), run by Cairo University at 1 site in Egypt.
Trial summary
This study is a randomized clinical trial comparing the effectiveness of conventional stabilization splints versus 3D-designed and printed stabilization splints in treating temporomandibular disorders (TMDs). TMD is a common cause of orofacial pain affecting the jaw joint and surrounding muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Conventional stabilization splint and 3D designed and printed stabilization splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged (18-40) presenting with myalgia.
Who cannot join
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized clinical trial comparing the effectiveness of conventional stabilization splints versus 3D-designed and printed stabilization splints in treating temporomandibular disorders (TMDs). TMD is a common cause of orofacial pain affecting the jaw joint and surrounding muscles. The trial evaluates outcomes such as pain reduction, clinical improvement, patient satisfaction, and time efficiency. By exploring a fully digital workflow for splint fabrication, this study aims to provide evidence on whether the newer 3D-printed approach offers superior results to conventional methods in terms of clinical effectiveness and procedural efficiency.
Read the detailed description
This study is a randomized clinical trial designed to evaluate the efficacy of 3D-designed and printed stabilization splints compared to conventional stabilization splints in managing temporomandibular disorders (TMDs) of muscular origin. TMD is a prevalent orofacial condition characterized by pain and dysfunction in the temporomandibular joint (TMJ) and associated structures, significantly impacting patients' quality of life. Stabilization splints are a widely used conservative treatment for TMD, aiming to alleviate symptoms by stabilizing occlusion, reducing parafunctional habits, and promoting muscle relaxation. Despite their popularity, controversies remain about their optimal design and long-term efficacy, especially with recent advancements in digital fabrication technologies.
Study Objectives The primary aim is to assess whether 3D-designed and printed stabilization splints offer superior clinical outcomes compared to conventional splints. Outcomes include pain reduction (measured using the Visual Analog Scale, VAS) and clinical improvement based on Diagnostic Criteria for TMD (DC/TMD) evaluations. Secondary objectives include measuring patient satisfaction, chairside time during splint fabrication, and changes in maximal unassisted incisal opening.
Study Design This is a single-blinded, randomized, parallel-group clinical trial with a 1:1 allocation ratio. The study will be conducted at the outpatient clinic of the Department of Orthodontics, Faculty of Dentistry, Cairo University. Adult patients aged 18-40 with muscular TMD are eligible, provided they meet inclusion criteria and have no prior orthodontic treatments.
Methodology
Participants will be randomly assigned to one of two groups:
Intervention Group: Patients will undergo direct intraoral scanning using a digital scanner. The data will be used to design and fabricate stabilization splints using a fully digital, 3D-printing workflow.
Comparator Group: Patients will have conventional alginate impressions taken. Stabilization splints will be fabricated using cold-cure acrylic resin.
Patients in both groups will be instructed to wear their splints at night only. Follow-up assessments will occur at 2, 4, 8, and 12 weeks to evaluate outcomes.
- Outcomes:
Primary:
- Measuring clinical improvement and pain level using VAS
Secondary:
- Measuring the patient satisfaction during wearing of the splint using VAS
- Chairside time taken during conventional splint impression and fabrication vs digital splint intraoral scan and design
- Changes in maximal incisal opening (fitting day/8 weeks) Significance This study addresses an important clinical question by comparing traditional and modern techniques for splint fabrication. By leveraging a digital workflow, it aims to provide insights into whether 3D-printed splints can improve clinical outcomes, enhance patient satisfaction, and reduce the time required for fabrication, potentially advancing TMD management practices.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Conventional stabilization splint, 3D designed and printed stabilization splints
- Keywords
- TMD Joint
- 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.
Conventional stabilization splintDevice
conventional versus 3D designed and printed stabilization splints
3D designed and printed stabilization splintsDevice
Conventional versus 3D designed and printed stabilization splints
| Study group | Role | What they receive |
|---|---|---|
| Conventional stabilization splint | Active comparator | Not described Receives: Device: Conventional stabilization splint |
| 3D designed and printed stabilization splint | Experimental | Not described Receives: Device: 3D designed and printed stabilization splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement
Visual analogue scale
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Ahmed Hassan, Cairo University
- Investigators
- Abdallah Ahmed Hassan Hamed Refai, MSc candidate, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781138
- Sponsor's protocol ID
- 2461994
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Versus 3D-Designed and Printed Stabilization Splints for Treatment of TMD Patients: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06781138
- Acronym / sponsor ID
- 2461994
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- TMD Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 17 Jan 2025 (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.
This study is a randomized clinical trial comparing the effectiveness of conventional stabilization splints versus 3D-designed and printed stabilization splints in treating temporomandibular disorders (TMDs). TMD is a common cause of orofacial pain affecting the jaw joint and surrounding muscles. The trial evaluates outcomes such as pain reduction, clinical improvement, patient satisfaction, and time efficiency. By exploring a fully digital workflow for splint fabrication, this study aims to provide evidence on whether the newer 3D-printed approach offers superior results to conventional methods in terms of clinical effectiveness and procedural efficiency.
Detailed description
This study is a randomized clinical trial designed to evaluate the efficacy of 3D-designed and printed stabilization splints compared to conventional stabilization splints in managing temporomandibular disorders (TMDs) of muscular origin. TMD is a prevalent orofacial condition characterized by pain and dysfunction in the temporomandibular joint (TMJ) and associated structures, significantly impacting patients' quality of life. Stabilization splints are a widely used conservative treatment for TMD, aiming to alleviate symptoms by stabilizing occlusion, reducing parafunctional habits, and promoting muscle relaxation. Despite their popularity, controversies remain about their optimal design and long-term efficacy, especially with recent advancements in digital fabrication technologies.
Study Objectives The primary aim is to assess whether 3D-designed and printed stabilization splints offer superior clinical outcomes compared to conventional splints. Outcomes include pain reduction (measured using the Visual Analog Scale, VAS) and clinical improvement based on Diagnostic Criteria for TMD (DC/TMD) evaluations. Secondary objectives include measuring patient satisfaction, chairside time during splint fabrication, and changes in maximal unassisted incisal opening.
Study Design This is a single-blinded, randomized, parallel-group clinical trial with a 1:1 allocation ratio. The study will be conducted at the outpatient clinic of the Department of Orthodontics, Faculty of Dentistry, Cairo University. Adult patients aged 18-40 with muscular TMD are eligible, provided they meet inclusion criteria and have no prior orthodontic treatments.
Methodology
Participants will be randomly assigned to one of two groups:
Intervention Group: Patients will undergo direct intraoral scanning using a digital scanner. The data will be used to design and fabricate stabilization splints using a fully digital, 3D-printing workflow.
Comparator Group: Patients will have conventional alginate impressions taken. Stabilization splints will be fabricated using cold-cure acrylic resin.
Patients in both groups will be instructed to wear their splints at night only. Follow-up assessments will occur at 2, 4, 8, and 12 weeks to evaluate outcomes.
- Outcomes:
Primary:
- Measuring clinical improvement and pain level using VAS
Secondary:
- Measuring the patient satisfaction during wearing of the splint using VAS
- Chairside time taken during conventional splint impression and fabrication vs digital splint intraoral scan and design
- Changes in maximal incisal opening (fitting day/8 weeks) Significance This study addresses an important clinical question by comparing traditional and modern techniques for splint fabrication. By leveraging a digital workflow, it aims to provide insights into whether 3D-printed splints can improve clinical outcomes, enhance patient satisfaction, and reduce the time required for fabrication, potentially advancing TMD management practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional stabilization splint | Active comparator | Device: Conventional stabilization splint |
| 3D designed and printed stabilization splint | Experimental | Device: 3D designed and printed stabilization splints |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged (18-40) presenting with myalgia.
Key exclusion criteria (1 listed)
- Previous orthodontic treatment.
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 |
|---|---|---|
| Conventional stabilization splintconventional versus 3D designed and printed stabilization splints | Device | Conventional stabilization splint |
| 3D designed and printed stabilization splintsConventional versus 3D designed and printed stabilization splints | Device | 3D designed and printed stabilization splint |
Primary outcome
clinical improvement
Time frame: after 8 weeks
Visual analogue scale
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 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Temporomandibular Disorders (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
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
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.
Abdallah Ahmed Hassan Hamed Refai, MSc candidate principal investigator
Cairo 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 Conventional stabilization splint and 3D designed and printed stabilization splints in people with Temporomandibular Disorders (TMD), run by Cairo 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 1 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: finished, as of the sponsor's last update on 17 Jan 2025. 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?
clinical improvement (time frame: after 8 weeks). 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 17 Jan 2025.