MalocclusionSARPENCT04670211
Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE.
An observational study of Malocclusion, run by ZOL.
Trial summary
The investigators will perform a prospective, non-randomized observational study. The aim of this study is to evaluate stability of tooth-borne, bone-borne and hybrid expansion following SARPE by using data collected according to the existing SARPE follow-up protocol. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- maxillary distractor
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing SARPE surgery due to maxillary transverse discrepancy
Who may be able to join
- Maxillary transverse discrepancy
- Skeletal mature patients
- SARPE treatment is indicated
Who cannot join
- Patients with a syndrome with an influence on head-and-neck morphology (such as Apert, Crouzon syndrome)
- Cleft patients
About this study
The investigators will perform a prospective, non-randomized observational study. The aim of this study is to evaluate stability of tooth-borne, bone-borne and hybrid expansion following SARPE by using data collected according to the existing SARPE follow-up protocol. The insights of this study might elucidate the preferred expansion technique and improve surgical technique.
Read the detailed description
Maxillary transverse discrepancy (MTD) is a difficult deformity to correct. In skeletal immature patients, an orthopedic-orthodontic expansion is the preferred treatment strategy. In case of a skeletal mature patient, a surgical treatment should be considered. A Surgically assisted Rapid Palatal Expansion (SARPE) procedure is a common surgical treatment for MTD in skeletal mature patients. In this procedure the skeletally mature, maxillary sutures are surgically reopened. One week postoperatively, the patient will activate the expander appliance. There are three widely-used expander appliances: tooth-borne, bone-borne and hybrid expanders. The use of the expander appliance is based on surgeon and referring orthodontist's common practice and preference. A tooth-borne expander is an appliance which is supported by the teeth and bridges the palate. A bone-borne expander is surgically placed at the level of the palate during SARPE surgery. Hybrid expansion is a combination of tooth-borne and bone-borne expansion. These appliances progressively widen the maxilla by daily activation of the distractor. The activation is stopped when the surgeon and/or referring orthodontist judge that the maxilla is sufficiently expanded. However, historical research with the use of cast model's and 2D posteroanterior cephalograms suggest that this expansion is not stable. With the emergence of 3D Cone-Beam Computed Tomography (CBCT) and its appliance as standard of care for pre-operative diagnosis and postoperative follow-up, stability and complications can be assessed more accurately. The goal of this study is to prospectively evaluate stability following SARPE, by analyzing the clinical and radiological data collected according to the existing clinical SARPE follow-up protocol. The secondary outcome is to evaluate complications following the three distractors.
- Conditions
- Malocclusion
- Being tested
- maxillary distractor
- Keywords
- SARPE, distraction osteogenesis, transverse maxillary hypoplasia
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary distractorDevice
the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor
| Study group | Role | What they receive |
|---|---|---|
| Tooth-borne distractor | Maxillary distraction with the use of a tooth-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. Receives: Device: maxillary distractor | |
| Bone-borne distractor | Maxillary distraction with the use of a bone-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. Receives: Device: maxillary distractor | |
| Hybrid distractor | Maxillary distraction with the use of a hybrid distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. Receives: Device: maxillary distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability
Stability of the maxillary expansion following SARPE. The stability will be evaluated by comparing the CBCT imaging which is taken at the time of maximal transversal maxillary expansion with the CBCT taken one year postoperatively. Width between the mesiobuccal cusps of the first molars and width between the cusps of the canines is measured. Moreover the width of the apertura piriformis and between the palatal foramen is examined in order to evaluate skeletal stability. This allows calculation of the dental and skeletal stability following SARPE.
Measured: 1 year postoperatively
Secondary outcomes (1)
Complications
Complications following SARPE surgery are examined. Anamnestic, clinical and radiographic information is examined in order to determine postoperative complications. The following complications can be examined: postoperative bleeding, mucosal infection, maxillary sinus infection, palatal necrosis, oro-antral communication, gingival recession, tooth discoloration, bone resorption, malunion, nonunion, root resorption, loss of teeth, mechanical failure of the distractor, asymmetric expansion, lacrimation.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- ZOL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver da Costa Senior, ZOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670211
- Sponsor's protocol ID
- CTU2020095
- Acronym
- SARPE
- Status last verified
- Apr 2021
- First submitted
- 1 Dec 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE.
- ClinicalTrials.gov ID
- NCT04670211
- Acronym / sponsor ID
- SARPE / CTU2020095
- Conditions
- Malocclusion
- Keywords
- SARPE, distraction osteogenesis, transverse maxillary hypoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ZOLUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Dec 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 investigators will perform a prospective, non-randomized observational study. The aim of this study is to evaluate stability of tooth-borne, bone-borne and hybrid expansion following SARPE by using data collected according to the existing SARPE follow-up protocol. The insights of this study might elucidate the preferred expansion technique and improve surgical technique.
Detailed description
Maxillary transverse discrepancy (MTD) is a difficult deformity to correct. In skeletal immature patients, an orthopedic-orthodontic expansion is the preferred treatment strategy. In case of a skeletal mature patient, a surgical treatment should be considered. A Surgically assisted Rapid Palatal Expansion (SARPE) procedure is a common surgical treatment for MTD in skeletal mature patients. In this procedure the skeletally mature, maxillary sutures are surgically reopened. One week postoperatively, the patient will activate the expander appliance. There are three widely-used expander appliances: tooth-borne, bone-borne and hybrid expanders. The use of the expander appliance is based on surgeon and referring orthodontist's common practice and preference. A tooth-borne expander is an appliance which is supported by the teeth and bridges the palate. A bone-borne expander is surgically placed at the level of the palate during SARPE surgery. Hybrid expansion is a combination of tooth-borne and bone-borne expansion. These appliances progressively widen the maxilla by daily activation of the distractor. The activation is stopped when the surgeon and/or referring orthodontist judge that the maxilla is sufficiently expanded. However, historical research with the use of cast model's and 2D posteroanterior cephalograms suggest that this expansion is not stable. With the emergence of 3D Cone-Beam Computed Tomography (CBCT) and its appliance as standard of care for pre-operative diagnosis and postoperative follow-up, stability and complications can be assessed more accurately. The goal of this study is to prospectively evaluate stability following SARPE, by analyzing the clinical and radiological data collected according to the existing clinical SARPE follow-up protocol. The secondary outcome is to evaluate complications following the three distractors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth-borne distractor | – | Device: maxillary distractorMaxillary distraction with the use of a tooth-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. |
| Bone-borne distractor | – | Device: maxillary distractorMaxillary distraction with the use of a bone-borne distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. |
| Hybrid distractor | – | Device: maxillary distractorMaxillary distraction with the use of a hybrid distractor following Surgically-assisted Rapid Palatal Expansion (SARPE) surgery. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing SARPE surgery due to maxillary transverse discrepancy
Key inclusion criteria (3 listed)
- Maxillary transverse discrepancy
- Skeletal mature patients
- SARPE treatment is indicated
Key exclusion criteria (2 listed)
- Patients with a syndrome with an influence on head-and-neck morphology (such as Apert, Crouzon syndrome)
- Cleft patients
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 |
|---|---|---|
| maxillary distractorthe type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor | Device | Bone-borne distractor, Hybrid distractor, Tooth-borne distractor |
Primary outcome
Stability
Time frame: 1 year postoperatively
Stability of the maxillary expansion following SARPE. The stability will be evaluated by comparing the CBCT imaging which is taken at the time of maximal transversal maxillary expansion with the CBCT taken one year postoperatively. Width between the mesiobuccal cusps of the first molars and width between the cusps of the canines is measured. Moreover the width of the apertura piriformis and between the palatal foramen is examined in order to evaluate skeletal stability. This allows calculation of the dental and skeletal stability following SARPE.
1 secondary outcome
Complications
Time frame: 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: Undecided. On request
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by ZOL.
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 2 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 20 Apr 2021. 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?
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?
Stability (time frame: 1 year postoperatively). 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 20 Apr 2021.