BruxismsplintNCT06652217
Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint
A study testing Digitally manufactured occlusal splint. and conventionally manufactured occlusal splint in people with Bruxism, run by Cairo University.
Trial summary
Each eligible patient will be randomly into one of two groups: Group A: The digital splint group, digital splint will be constructed to each patient. Group B: The conventional splint group, conventional splint will be constructed to each patient. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Digitally manufactured occlusal splint. and conventionally manufactured occlusal splint
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically healthy patients.
- Patients with signs (as teeth attrition, muscles hypertrophy, and increased muscles activity) and symptoms (as muscles pain, headache, patient reporting) of bruxism for the last 6 months with no condylar or disc attrition.
- Fully dentate with presence of first molar in both arches
- Patients with good oral hygiene.
- Absence of any intra-oral pathological condition. Exclusion Criteria:• Patients with a history of psychosomatic disease.
- Patients with addiction to alcohol, drugs, or analgesics.
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- Pregnant patients.
- Patients with malignant disease.
- Acute events such as trauma or inflammation.
- Bisphosphonate therapy within the last 5 years.
- Removable dental prostheses.
- Known hypersensitivity to materials.
- Extensive temporomandibular disorder that renders the stabilizing splints not to be the treatment of choice.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint (Randomized Clinical Trial)
Each eligible patient will be randomly into one of two groups:
Group A: The digital splint group, digital splint will be constructed to each patient.
Read more
Group B: The conventional splint group, conventional splint will be constructed to each patient.
- For both groups, thorough clinical examination, scaling and root-planning will be done. Patient will receive a motivational oral hygiene program with detailed explanation regarding the study process and outcome expectations.
- A precise history and clinical examination will be done by (F.M) under supervision of Dr S.G.
The digital splint construction method:
- First, complete arch intraoral digital scans of the maxillary and mandibular arches will be performed using the intra oral scanner following the scanning protocol recommended by the manufacturer.
- For inter maxillary relation recording using optical jaw tracking device, step-by-step procedure for tracking and recording the maxillomandibular relationship and mandibular motion by using an optical jaw tracking system will be illustrated to the patient.
- The occlusal device will be designed using a CAD software program.
- The occlusal device will be printed using a 3D printer
- The occlusal device will be finished and polished manually.
The conventional splint construction method:
- The first step is making an impression using a quick-setting addition polyvinyl siloxane impression material. A stone model will be obtained after pouring the impression using extra-hard dental stone.
- In the second visit a face bow transfer and a centric relation record will be utilized to mount the casts on a semi adjustable articulator.
- For centric relation recording, a jig will be made with an incisal plateau from modeling plastic impression compound and the jig will be inserted between the central incisors. To measure centric relation as precisely as possible (by avoiding translational movement in the temporomandibular joint),
- The jig will be adjusted with a scalpel to create a distance of no more than 2 mm between the maxillary and mandibular arches. Then the relation will be recorded using a fast-setting polyvinyl siloxane occlusal registration material. The occlusal registrations will be trimmed to the buccal cusp tips to be transferred accurately to the articulator without interference.
- After mounting of the centric relation the protrusive record will be taken and the horizontal condylar angle will be adjusted accordingly.
- The device will be fabricated from clear prosthetic resin. Production followed a standardized protocol with a minimum inter maxillary thickness of 1.5 mm and a buccal extension to 1 mm below the survey line.
- The device will be finished and occlusion will be adjusted on the articulator. outcomes assessment:
- Occlusal force distribution will be measured using osslusosense.
- Cost effectiveness will be assessed using the following equation(CE ratio = C/E).
- Conditions
- Bruxism
- Being tested
- Digitally manufactured occlusal splint., conventionally manufactured occlusal splint
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally manufactured occlusal splint.Device
digitally manfactured occlusal splint using intra oral scanner and jaw traccking device for data acqusition and 3d printing for manfacturing of the device
conventionally manufactured occlusal splintDevice
the occlusal device will be manufactured conventionally using impression and and anterior deprogramer with bite registeration material for data aquesition and usual construction method using clear acrylic.
| Study group | Role | What they receive |
|---|---|---|
| Digitally manufactured occlusal splint | Experimental | digitally manfactured occlusal splint using intra oral scanner and jaw traccking device for data acqusition and 3d printing for manfacturing of the device Receives: Device: Digitally manufactured occlusal splint. |
| conventionally manufactured occlusal splint | Active comparator | the occlusal device will be manufactured conventionally using impression and and anterior deprogramer with bite registeration material for data aquesition and usual construction method using clear acrylic. Receives: Device: conventionally manufactured occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusal force distribution
the distribution of force between right and left side will be assessed using occlusosense device
Measured: the outcome will be measured immediately after the device insertion
Secondary outcomes (1)
cost effectiveness
the cost effectiveness will be measured using the following equation (CE ratio = C/E)
Measured: the outcome will be measured immediately after the device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma hussein abd elmonem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652217
- Sponsor's protocol ID
- 2497
- Other IDs
- ethics comittee
- Acronym
- splint
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: iam not going to share the IPD for privacy and security of the informations
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06652217
- Acronym / sponsor ID
- splint / 2497
- Conditions
- Bruxism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
Each eligible patient will be randomly into one of two groups:
Group A: The digital splint group, digital splint will be constructed to each patient.
Group B: The conventional splint group, conventional splint will be constructed to each patient.
- For both groups, thorough clinical examination, scaling and root-planning will be done. Patient will receive a motivational oral hygiene program with detailed explanation regarding the study process and outcome expectations.
- A precise history and clinical examination will be done by (F.M) under supervision of Dr S.G.
The digital splint construction method:
- First, complete arch intraoral digital scans of the maxillary and mandibular arches will be performed using the intra oral scanner following the scanning protocol recommended by the manufacturer.
- For inter maxillary relation recording using optical jaw tracking device, step-by-step procedure for tracking and recording the maxillomandibular relationship and mandibular motion by using an optical jaw tracking system will be illustrated to the patient.
- The occlusal device will be designed using a CAD software program.
- The occlusal device will be printed using a 3D printer
- The occlusal device will be finished and polished manually.
The conventional splint construction method:
- The first step is making an impression using a quick-setting addition polyvinyl siloxane impression material. A stone model will be obtained after pouring the impression using extra-hard dental stone.
- In the second visit a face bow transfer and a centric relation record will be utilized to mount the casts on a semi adjustable articulator.
- For centric relation recording, a jig will be made with an incisal plateau from modeling plastic impression compound and the jig will be inserted between the central incisors. To measure centric relation as precisely as possible (by avoiding translational movement in the temporomandibular joint),
- The jig will be adjusted with a scalpel to create a distance of no more than 2 mm between the maxillary and mandibular arches. Then the relation will be recorded using a fast-setting polyvinyl siloxane occlusal registration material. The occlusal registrations will be trimmed to the buccal cusp tips to be transferred accurately to the articulator without interference.
- After mounting of the centric relation the protrusive record will be taken and the horizontal condylar angle will be adjusted accordingly.
- The device will be fabricated from clear prosthetic resin. Production followed a standardized protocol with a minimum inter maxillary thickness of 1.5 mm and a buccal extension to 1 mm below the survey line.
- The device will be finished and occlusion will be adjusted on the articulator. outcomes assessment:
- Occlusal force distribution will be measured using osslusosense.
- Cost effectiveness will be assessed using the following equation(CE ratio = C/E).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitally manufactured occlusal splint | Experimental | Device: Digitally manufactured occlusal splint.digitally manfactured occlusal splint using intra oral scanner and jaw traccking device for data acqusition and 3d printing for manfacturing of the device |
| conventionally manufactured occlusal splint | Active comparator | Device: conventionally manufactured occlusal splintthe occlusal device will be manufactured conventionally using impression and and anterior deprogramer with bite registeration material for data aquesition and usual construction method using clear acrylic. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Medically healthy patients.
- Patients with signs (as teeth attrition, muscles hypertrophy, and increased muscles activity) and symptoms (as muscles pain, headache, patient reporting) of bruxism for the last 6 months with no condylar or disc attrition.
- Fully dentate with presence of first molar in both arches
- Patients with good oral hygiene.
- Absence of any intra-oral pathological condition. Exclusion Criteria:• Patients with a history of psychosomatic disease.
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 |
|---|---|---|
| Digitally manufactured occlusal splint.digitally manfactured occlusal splint using intra oral scanner and jaw traccking device for data acqusition and 3d printing for manfacturing of the device | Device | Digitally manufactured occlusal splint |
| conventionally manufactured occlusal splintthe occlusal device will be manufactured conventionally using impression and and anterior deprogramer with bite registeration material for data aquesition and usual construction method using clear acrylic. | Device | conventionally manufactured occlusal splint |
Primary outcome
occlusal force distribution
Time frame: the outcome will be measured immediately after the device insertion
the distribution of force between right and left side will be assessed using occlusosense device
1 secondary outcome
cost effectiveness
Time frame: the outcome will be measured immediately after the device insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No. iam not going to share the IPD for privacy and security of the informations
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally manufactured occlusal splint. and conventionally manufactured occlusal splint in people with Bruxism, run by Cairo University.
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 13 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 fatma H saleh, master of prosthodontics (+201011164489, fatma.hussein@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occlusal force distribution (time frame: the outcome will be measured immediately after the device insertion). 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 22 Oct 2024.