Maxillary HypoplasiaNCT01770782
Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner
A study testing Surgically Assisted Rapid Maxillary Expansion (SARME) and Laser Scanner in people with Maxillary Hypoplasia, run by Max Domingues Pereira at 1 site in Brazil.
Trial summary
The objective of this study was to evaluate the effect of the orthodontic retainer on transverse maxillary dental and skeletal stability after SARME. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Maxillary Hypoplasia
- What is being tested?
- Surgically Assisted Rapid Maxillary Expansion (SARME) and Laser Scanner
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Jan 2011
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with bilateral transverse maxillary deficiencies greater than 5 mm
Who cannot join
- Patients with previous histories of maxillary surgery,
- congenital craniofacial malformations and
- unilateral transverse maxillary deficiencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orthodontic Retention on Dental and Skeletal Maxillary Transverse Stability After Surgically Assisted Rapid Maxillary Expansion (SARME)Using Laser Scanner
The objective of this study was to evaluate the effect of the orthodontic retainer on transverse maxillary dental and skeletal stability after SARME.
Read the detailed description
Methods: Ninety digitized dental casts of 30 adult patients (18 males and 12 females) submitted to SARME using the Hyrax expansion appliance were evaluated. Patients were distributed into two groups: Group Without Retention (GSC) n = 15; and Group With Retention (GCC) n = 15. In the GCC group, a Transpalatal Arch (TPA) was installed for retention soon after removal of the expander. The dental casts were scanned using a Vivid 9i 3D laser scanner (Konica Minolta, Wayne, NJ). The plaster models were performed preoperatively (T1), 4 months after the expander was removed (T2), and 10 months after the end of the expansion (T3). The distances measured were Inter-Cusps of Premolars and Molars (Inter-Cusp PM) (Inter-Cusp M), Inter-Cervicals of Premolars and Molars (Inter-Cervical PM) (Inter-Cervical M), Inter-WALA edges of Premolars and Molars (PM Inter-BW) (BW Inter-M), palatal height at the molar, and palatal area and volume at T1, T2, and T3.
- Conditions
- Maxillary Hypoplasia
- Being tested
- Surgically Assisted Rapid Maxillary Expansion (SARME), Laser Scanner
- Keywords
- Palatal Expansion Technique, Orthognathic Surgery, Three Dimensional images
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgically Assisted Rapid Maxillary Expansion (SARME)Procedure or surgery
Surgical technique is performed with subtotal LeFort I osteotomy with separation of the pterygomaxillary fissure.The procedure was performed under general anesthesia using endotracheal intubation. Following the osteotomies, the expander screw was activated to 1.6 mm intraoperatively until a small diastema was observed between the upper central incisors. The incision was sutured along two planes.
Laser ScannerOther
Laser Scanner Vivid 9i was used to digitize the study models. The 3d virtual dental casts is a reliable copy of the original dental casts. On this virtual casts all measurements (linear, area and volume of the palate) was done to evaluate the stability after SARME.
| Study group | Role | What they receive |
|---|---|---|
| Laser Scanner | Other | Laser Scanner (Vivid 9i® - Konica Minolta)was used to digitize the study casts. After scanning the dental casts a 3D virtual dental casts was used to realize all measurements (pre-treatment, 4 months and 10 months). Receives: Other: Laser Scanner |
| SARME | Other | Surgically Assisted rapid Maxillary Expansion -SARME was used for the treatment of transverse maxillary deficiency.This procedure is a combination of a surgical procedure and orthopedic expansion of the maxilla. Receives: Procedure: Surgically Assisted Rapid Maxillary Expansion (SARME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Stability
Laser scanner to create a 3D virtual dental cast
Measured: up to 10 months after the end of expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionJan 2011
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Domingues Pereira
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-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 PauloJoão PR Biló, MD, Study chair, Federal University of São PauloLydia M Ferreira, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770782
- Sponsor's protocol ID
- 0949/09
- Status last verified
- Jul 2009
- First submitted
- 16 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prado GP, Pereira MD, Bilo JP, Furtado F, Ferreira LM. Stability of surgically assisted rapid palatal expansion: a randomized trial. J Dent Res. 2013 Jul;92(7 Suppl):49S-54S. doi: 10.1177/0022034513486899. Epub 2013 May 20.
PubMed 23690355
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Retention on Dental and Skeletal Maxillary Transverse Stability After Surgically Assisted Rapid Maxillary Expansion (SARME)Using Laser Scanner
- ClinicalTrials.gov ID
- NCT01770782
- Acronym / sponsor ID
- 0949/09
- Conditions
- Maxillary Hypoplasia
- Keywords
- Palatal Expansion Technique, Orthognathic Surgery, Three Dimensional images
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Max Domingues PereiraUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Jan 2013 (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.
The objective of this study was to evaluate the effect of the orthodontic retainer on transverse maxillary dental and skeletal stability after SARME.
Detailed description
Methods: Ninety digitized dental casts of 30 adult patients (18 males and 12 females) submitted to SARME using the Hyrax expansion appliance were evaluated. Patients were distributed into two groups: Group Without Retention (GSC) n = 15; and Group With Retention (GCC) n = 15. In the GCC group, a Transpalatal Arch (TPA) was installed for retention soon after removal of the expander. The dental casts were scanned using a Vivid 9i 3D laser scanner (Konica Minolta, Wayne, NJ). The plaster models were performed preoperatively (T1), 4 months after the expander was removed (T2), and 10 months after the end of the expansion (T3). The distances measured were Inter-Cusps of Premolars and Molars (Inter-Cusp PM) (Inter-Cusp M), Inter-Cervicals of Premolars and Molars (Inter-Cervical PM) (Inter-Cervical M), Inter-WALA edges of Premolars and Molars (PM Inter-BW) (BW Inter-M), palatal height at the molar, and palatal area and volume at T1, T2, and T3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Scanner | Other | Other: Laser ScannerLaser Scanner (Vivid 9i® - Konica Minolta)was used to digitize the study casts. After scanning the dental casts a 3D virtual dental casts was used to realize all measurements (pre-treatment, 4 months and 10 months). |
| SARME | Other | Procedure: Surgically Assisted Rapid Maxillary Expansion (SARME)Surgically Assisted rapid Maxillary Expansion -SARME was used for the treatment of transverse maxillary deficiency.This procedure is a combination of a surgical procedure and orthopedic expansion of the maxilla. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients with bilateral transverse maxillary deficiencies greater than 5 mm
Key exclusion criteria (3 listed)
- Patients with previous histories of maxillary surgery,
- congenital craniofacial malformations and
- unilateral transverse maxillary deficiencies
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 |
|---|---|---|
| Surgically Assisted Rapid Maxillary Expansion (SARME)Surgical technique is performed with subtotal LeFort I osteotomy with separation of the pterygomaxillary fissure.The procedure was performed under general anesthesia using endotracheal intubation. Following the osteotomies, the expander screw was activated to 1.6 mm intraoperatively until a small diastema was observed between the upper central incisors. The incision was sutured along two planes. | Procedure or surgery | SARME |
| Laser ScannerLaser Scanner Vivid 9i was used to digitize the study models. The 3d virtual dental casts is a reliable copy of the original dental casts. On this virtual casts all measurements (linear, area and volume of the palate) was done to evaluate the stability after SARME. | Other | Laser Scanner |
Primary outcome
Maxillary Stability
Time frame: up to 10 months after the end of expansion
Laser scanner to create a 3D virtual dental cast
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 Jan 2013.
- Derived from this study: PubMed 23690355Prado GP, Pereira MD, Bilo JP, Furtado F, Ferreira LM. Stability of surgically assisted rapid palatal expansion: a randomized trial. J Dent Res. 2013 Jul;92(7 Suppl):49S-54S. doi: 10.1177/0022034513486899. Epub 2013 May 20.
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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.
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 Surgically Assisted Rapid Maxillary Expansion (SARME) and Laser Scanner in people with Maxillary Hypoplasia, run by Max Domingues Pereira 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 1 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: finished, as of the sponsor's last update on 18 Jan 2013. 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?
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?
Maxillary Stability (time frame: up to 10 months after the end of expansion). 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 NCT01770782, 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 Jan 2013.