Maxillary Hypoplasia3S/2S_SARPENCT02179593
Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial
A study testing 2-Segment SARPE and 3-Segment SARPE in people with Maxillary Hypoplasia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Maxillary Hypoplasia
- What is being tested?
- 2-Segment SARPE and 3-Segment SARPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to Dec 2016
- 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being healthy and literate
- Having 7-millimeter transverse maxilla deficiency bilaterally distributed.
Who cannot join
- Having undergone maxilla surgery previously
- Having craniofacial anomaly
- Having excessive dental crowding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial
A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.
Read the detailed description
32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.
The participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.
Individuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.
All participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.
The expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.
- Conditions
- Maxillary Hypoplasia
- Being tested
- 2-Segment SARPE, 3-Segment SARPE
- Keywords
- Maxillary expansion, Orthognathic surgery, Symmetry, Palatal expansion technique, Maxilla abnormality
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Segment SARPEOther
Also called Surgically Assisted Rapid Maxillary Expansion (SARME), Surgically Assisted Rapid Palatal Expansion (SARPE)
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
3-Segment SARPEOther
Also called Surgically Assisted Rapid Palatal Expansion (SARPE), Surgically Assisted Rapid MaxillaryExpansion (SARME)
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
| Study group | Role | What they receive |
|---|---|---|
| 2-Segment SARPE | Other | Maxilla expansion using one sagittal section of the maxilla. Receives: Other: 2-Segment SARPE |
| 3-Segment SARPE | Other | Maxilla Expansion using two parasagittal section of the maxilla. Receives: Other: 3-Segment SARPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies.
Measured: An average of 2 weeks after expansion.
Secondary outcomes (3)
Maxillary symmetry
The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software.
Measured: pre-operative and an average of 2 weeks at the end of maxillary expansion.
Stability of dental and osseous structures
The stability of dental and osseous structures will be analyzed using computer-aided 3D analysis of data obtained through the scanning of dental casts using Bicam 3D scanner (Scaierman - Italy).
Measured: pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.
Nasal and paranasal topographic changes
The nasal and paranasal topographic changes will be captured using laser scanner device.
Measured: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary HypoplasiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Domingues Pereira, Federal University of São Paulo
- Investigators
- Max D Pereira, PhD, Principal investigator, Federal University of São PauloGabriela PR Prado, MS, Study chair, Federal University of São PauloFabianne MG Furtado, PhD, Study chair, Federal University of São PauloLydia M Ferreira, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179593
- Sponsor's protocol ID
- 464.869
- Acronym
- 3S/2S_SARPE
- Status last verified
- Mar 2016
- First submitted
- 29 Jun 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02179593
- Acronym / sponsor ID
- 3S/2S_SARPE / 464.869
- Conditions
- Maxillary Hypoplasia
- Keywords
- Maxillary expansion, Orthognathic surgery, Symmetry, Palatal expansion technique, Maxilla abnormality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- 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.
A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.
Detailed description
32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.
The participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.
Individuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.
All participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.
The expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-Segment SARPE | Other | Other: 2-Segment SARPEMaxilla expansion using one sagittal section of the maxilla. |
| 3-Segment SARPE | Other | Other: 3-Segment SARPEMaxilla Expansion using two parasagittal section of the maxilla. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Being healthy and literate
- Having 7-millimeter transverse maxilla deficiency bilaterally distributed.
Key exclusion criteria (3 listed)
- Having undergone maxilla surgery previously
- Having craniofacial anomaly
- Having excessive dental crowding.
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 |
|---|---|---|
| 2-Segment SARPEAlso: Surgically Assisted Rapid Maxillary Expansion (SARME), Surgically Assisted Rapid Palatal Expansion (SARPE)Le Fort I osteotomy with oppening of the median palatal suture and SARPE. | Other | 2-Segment SARPE |
| 3-Segment SARPEAlso: Surgically Assisted Rapid Palatal Expansion (SARPE), Surgically Assisted Rapid MaxillaryExpansion (SARME)Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE. | Other | 3-Segment SARPE |
Primary outcome
Quality of Life
Time frame: An average of 2 weeks after expansion.
The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies.
3 secondary outcomes
Maxillary symmetry
Time frame: pre-operative and an average of 2 weeks at the end of maxillary expansion.
Stability of dental and osseous structures
Time frame: pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.
Nasal and paranasal topographic changes
Time frame: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Related trials for Maxillary Hypoplasia
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
Recruiting
3D Printed Reverse Twin Block for Class III Malocclusion
Class III Malocclusion
Recruiting
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Posterior Crossbite, Maxilla; Hypoplasia
Recruiting
Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment
Dental Malocclusion, Maxillary Deficiency
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.
Max D Pereira, PhD principal investigator
Federal University of São Paulo
Gabriela PR Prado, MS study chair
Federal University of São Paulo
Fabianne MG Furtado, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Segment SARPE and 3-Segment SARPE in people with Maxillary Hypoplasia, run by Federal University of São Paulo at 1 site in Brazil.
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 2 inclusion and 3 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 16 Mar 2016. 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 Brazil. 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?
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?
Quality of Life (time frame: An average of 2 weeks after expansion.). 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 16 Mar 2016.