Occlusal SplintsNCT05317182
Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.
A study testing Occlusal Splints Analogic-Analogic, Occlusal Splints Analogic-Digital and Occlusal Splints Digital-Digital in people with Occlusal Splints, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusal Splints
- What is being tested?
- Occlusal Splints Analogic-Analogic, Occlusal Splints Analogic-Digital and Occlusal Splints Digital-Digital
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2022to 30 Apr 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 to 70 years old.
- Patients who maintain until first molar in both arches.
- Patients who need occlusal splints due to bruxism.
Who cannot join
- Pregnant patients.
- Patients with removable prostheses.
- Patients with fixed prostheses between six to six in both arches.
- Patients with partial edentulism, do not maintain until first molar in both arches.
- Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®."
To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled.
Read the detailed description
Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment).
- Conditions
- Occlusal Splints
- Being tested
- Occlusal Splints Analogic-Analogic, Occlusal Splints Analogic-Digital, Occlusal Splints Digital-Digital
- Keywords
- Digital Dentistry, Occlusal records, Intraoral scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal Splints Analogic-AnalogicOther
Take a conventional impression to the patient and conventional fabrication of the splint.
Occlusal Splints Analogic-DigitalOther
Take a conventional impression to the patient and digital fabrication of the splint.
Occlusal Splints Digital-DigitalOther
Take a digital impression to the patient and digital fabrication of the splint.
| Study group | Role | What they receive |
|---|---|---|
| Analogic-Analogic | Active comparator | Occlusal splints made by conventional impression and conventional fabrication. Receives: Other: Occlusal Splints Analogic-Analogic |
| Analogic-Digital | Active comparator | Occlusal splints made by conventional impression and digital design and fabrication. Receives: Other: Occlusal Splints Analogic-Digital |
| Digital-Digital | Active comparator | Occlusal splints performed by intra-oral scanner and digital design and fabrication. Receives: Other: Occlusal Splints Digital-Digital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric changes assessed in Root Mean Square (RMS)
The software of automatically graphical comparisons called Geomagic® Control X (Geomagic Inc., 3D Systems Inc., USA) will be used to calculate the accuracy by measuring the distance (positive or negative) from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). This approach will give us the mean of the simple arithmetic difference.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start17 Feb 2022
- Primary completion15 Apr 2022
- Study completion30 Apr 2022
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 Occlusal SplintsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3). Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Blasi, Universitat Internacional de Catalunya
- Investigators
- Miguel Roig, DDS, PhD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317182
- Sponsor's protocol ID
- REST-ECL-2021-07
- Status last verified
- May 2022
- First submitted
- 6 Mar 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blasi A, Henarejos-Domingo V, Palacios-Banuelos R, Aparicio C, Roig M. Comparison accuracy of digital and analog method using milled occlusal splints. J Esthet Restor Dent. 2023 Oct;35(7):1103-1112. doi: 10.1111/jerd.13039. Epub 2023 Mar 21.
PubMed 36942721
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®."
- ClinicalTrials.gov ID
- NCT05317182
- Acronym / sponsor ID
- REST-ECL-2021-07
- Conditions
- Occlusal Splints
- Keywords
- Digital Dentistry, Occlusal records, Intraoral scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 Apr 2022 (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.
To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled.
Detailed description
Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3). Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.
| Arm | Type | Receives |
|---|---|---|
| Analogic-Analogic | Active comparator | Other: Occlusal Splints Analogic-AnalogicOcclusal splints made by conventional impression and conventional fabrication. |
| Analogic-Digital | Active comparator | Other: Occlusal Splints Analogic-DigitalOcclusal splints made by conventional impression and digital design and fabrication. |
| Digital-Digital | Active comparator | Other: Occlusal Splints Digital-DigitalOcclusal splints performed by intra-oral scanner and digital design and fabrication. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 to 70 years old.
- Patients who maintain until first molar in both arches.
- Patients who need occlusal splints due to bruxism.
Key exclusion criteria (5 listed)
- Pregnant patients.
- Patients with removable prostheses.
- Patients with fixed prostheses between six to six in both arches.
- Patients with partial edentulism, do not maintain until first molar in both arches.
- Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.
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 |
|---|---|---|
| Occlusal Splints Analogic-AnalogicTake a conventional impression to the patient and conventional fabrication of the splint. | Other | Analogic-Analogic |
| Occlusal Splints Analogic-DigitalTake a conventional impression to the patient and digital fabrication of the splint. | Other | Analogic-Digital |
| Occlusal Splints Digital-DigitalTake a digital impression to the patient and digital fabrication of the splint. | Other | Digital-Digital |
Primary outcome
Volumetric changes assessed in Root Mean Square (RMS)
Time frame: 1 week
The software of automatically graphical comparisons called Geomagic® Control X (Geomagic Inc., 3D Systems Inc., USA) will be used to calculate the accuracy by measuring the distance (positive or negative) from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). This approach will give us the mean of the simple arithmetic difference.
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 May 2022.
- Derived from this study: PubMed 36942721Blasi A, Henarejos-Domingo V, Palacios-Banuelos R, Aparicio C, Roig M. Comparison accuracy of digital and analog method using milled occlusal splints. J Esthet Restor Dent. 2023 Oct;35(7):1103-1112. doi: 10.1111/jerd.13039. Epub 2023 Mar 21.
- 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.
Miguel Roig, DDS, PhD study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal Splints Analogic-Analogic, Occlusal Splints Analogic-Digital and Occlusal Splints Digital-Digital in people with Occlusal Splints, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 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 May 2022. 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 Spain. 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?
Volumetric changes assessed in Root Mean Square (RMS) (time frame: 1 week). 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 NCT05317182, 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 18 May 2022.