Dentofacial DeformitiesNCT04224805
The Use of Bone-borne Guides in Orthognathic Surgery Cases
A study testing Bone-borne CAD/CAM splint and 3D interocclusal conventional splint in people with Dentofacial Deformities, run by Alexandria University at 1 site in Egypt.
Trial summary
The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Bone-borne CAD/CAM splint and 3D interocclusal conventional splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 30 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with dentofacial deformity requiring Le Fort I osteotomy
Who cannot join
- Patients with severe asymmetry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Bone-borne CAD/CAM Surgical Guides in Orthognathic Surgery Cases Requiring Le Fort I Osteotomy
The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.
Read the detailed description
Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.
- Conditions
- Dentofacial Deformities
- Being tested
- Bone-borne CAD/CAM splint, 3D interocclusal conventional splint
- Keywords
- Le Fort, Orthognathic surgery, Virtual surgical planning
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-borne CAD/CAM splintDevice
3D printed splint that repositions the maxilla with the zygomatic buttress as a reference.
3D interocclusal conventional splintDevice
Interocclusal splint that relies on the centric relation of the condyle as well as occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Interocclusal conventional splint is used to reposition the maxilla. Receives: Device: 3D interocclusal conventional splint |
| Study | Experimental | Bone-borne splint is used to reposition the maxilla. Receives: Device: Bone-borne CAD/CAM splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error of superimposition
Superimposition error between planned and actual maxillary position
Measured: 2 weeks
Secondary outcomes (2)
Visual Analogue Scale
Pain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.
Measured: 3 months
Procedure duration
Time of the surgery using the splint
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Nov 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohammed Abou Eleneen, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224805
- Sponsor's protocol ID
- AlexandriaU- FacDentistry
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Bone-borne CAD/CAM Surgical Guides in Orthognathic Surgery Cases Requiring Le Fort I Osteotomy
- ClinicalTrials.gov ID
- NCT04224805
- Acronym / sponsor ID
- AlexandriaU- FacDentistry
- Conditions
- Dentofacial Deformities
- Keywords
- Le Fort, Orthognathic surgery, Virtual surgical planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 13 Jan 2020 (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 present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.
Detailed description
Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: 3D interocclusal conventional splintInterocclusal conventional splint is used to reposition the maxilla. |
| Study | Experimental | Device: Bone-borne CAD/CAM splintBone-borne splint is used to reposition the maxilla. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with dentofacial deformity requiring Le Fort I osteotomy
Key exclusion criteria (1 listed)
- Patients with severe asymmetry
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 |
|---|---|---|
| Bone-borne CAD/CAM splint3D printed splint that repositions the maxilla with the zygomatic buttress as a reference. | Device | Study |
| 3D interocclusal conventional splintInterocclusal splint that relies on the centric relation of the condyle as well as occlusion. | Device | Control |
Primary outcome
Error of superimposition
Time frame: 2 weeks
Superimposition error between planned and actual maxillary position
2 secondary outcomes
Visual Analogue Scale
Time frame: 3 months
Procedure duration
Time frame: 1 day
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 13 Jan 2020.
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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 Bone-borne CAD/CAM splint and 3D interocclusal conventional splint in people with Dentofacial Deformities, run by Alexandria 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 13 Jan 2020. 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?
Error of superimposition (time frame: 2 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 13 Jan 2020.