MalocclusionSARMENCT03503448
Comparison of 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
A study testing Osteotomy between the maxillary central incisors and Osteotomy between the maxillary lateral incisors and canines in people with Malocclusion and Maxillar Hypoplasia, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in the treatment of maxillary transverse deficiency. Half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Maxillar Hypoplasia, Transverse Maxillary Deficiency
- What is being tested?
- Osteotomy between the maxillary central incisors and Osteotomy between the maxillary lateral incisors and canines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2018to 5 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: patients with bilateral cross-bite and bilateral transverse maxillary deficiencies equal to or greater than 6 mm -
Exclusion Criteria: Patients with previous histories of maxillary surgery, congenital craniofacial malformations, unilateral transverse maxillary deficiencies and absence of teeth in the maxilla.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in the treatment of maxillary transverse deficiency. Half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).
Read the detailed description
Surgically Assisted Rapid Maxillary Expansion (SARME) can be performed by a osteotomy between the maxillary central incisors and by osteotomies between the maxillary lateral incisors and canines (bilateral).
Both techniques treat transverse maxillary hypoplasia, but they do so with different effects on esthetics, periodontium, teeth and bone expansion.
- Being tested
- Osteotomy between the maxillary central incisors, Osteotomy between the maxillary lateral incisors and canines
- Keywords
- surgically assisted rapid maxillary expansion, surgically assisted rapid palatal expansion, Malocclusion
- Medical subject headings
- Malocclusion, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteotomy between the maxillary central incisorsProcedure or surgery
Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.
Osteotomy between the maxillary lateral incisors and caninesProcedure or surgery
Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines
| Study group | Role | What they receive |
|---|---|---|
| space between 11/21 | Other | Osteotomy between the maxillary central incisors Receives: Procedure: Osteotomy between the maxillary central incisors |
| space between 12/13 and 22/23 | Other | Osteotomy between the maxillary lateral incisors and canines Receives: Procedure: Osteotomy between the maxillary lateral incisors and canines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone expansion and dental inclination
Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images
Measured: 1-2 months post-expansion.
Secondary outcomes (3)
Patient´s perception
Patient´s cosmetic perception of his or her smile on a visual analogue scale (VAS) ranging from 0 to 10, where "0" represents total dissatisfaction and "10" represents total satisfaction with the postoperative smile.
Measured: 2 months post-expansion.
Periodontal effects
Assessment of periodontal changes in the teeth adjacent to the segmentation, through periodontal probing
Measured: 2 months post-expansion.
Surgery time
Time elapsed during surgery.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start7 May 2018
- Primary completion22 Jul 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Andre Alves Pereira, Hospital Universitario Pedro Ernesto
- Investigators
- Fabio G Ritto, PhD, Study chair, Hospital Universitario Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503448
- Sponsor's protocol ID
- 69696317.0.0000.5259
- Acronym
- SARME
- Status last verified
- Feb 2020
- First submitted
- 1 Apr 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I plan to share the data on March 24, 2020 when I going to present my Master degrees' thesis. I tried to submit an article with the data. I'm waiting for a reply
Publications
Landes CA, Laudemann K, Petruchin O, Mack MG, Kopp S, Ludwig B, Sader RA, Seitz O. Comparison of bipartite versus tripartite osteotomy for maxillary transversal expansion using 3-dimensional preoperative and postexpansion computed tomography data. J Oral Maxillofac Surg. 2009 Oct;67(10):2287-301. doi: 10.1016/j.joms.2009.04.069.
PubMed 19761925Betts NJ. Surgically Assisted Maxillary Expansion. Atlas Oral Maxillofac Surg Clin North Am. 2016 Mar;24(1):67-77. doi: 10.1016/j.cxom.2015.10.003. Epub 2015 Nov 24. No abstract available.
PubMed 26847514Camps-Pereperez I, Guijarro-Martinez R, Peiro-Guijarro MA, Hernandez-Alfaro F. The value of cone beam computed tomography imaging in surgically assisted rapid palatal expansion: a systematic review of the literature. Int J Oral Maxillofac Surg. 2017 Jul;46(7):827-838. doi: 10.1016/j.ijom.2017.01.017. Epub 2017 Mar 6.
PubMed 28279603
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing 2 Techniques of Surgically Assisted Rapid Maxillary Expansion
- ClinicalTrials.gov ID
- NCT03503448
- Acronym / sponsor ID
- SARME / 69696317.0.0000.5259
- Keywords
- surgically assisted rapid maxillary expansion, surgically assisted rapid palatal expansion, Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 19 Apr 2018 (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.
This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in the treatment of maxillary transverse deficiency. Half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).
Detailed description
Surgically Assisted Rapid Maxillary Expansion (SARME) can be performed by a osteotomy between the maxillary central incisors and by osteotomies between the maxillary lateral incisors and canines (bilateral).
Both techniques treat transverse maxillary hypoplasia, but they do so with different effects on esthetics, periodontium, teeth and bone expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| space between 11/21 | Other | Procedure: Osteotomy between the maxillary central incisorsOsteotomy between the maxillary central incisors |
| space between 12/13 and 22/23 | Other | Procedure: Osteotomy between the maxillary lateral incisors and caninesOsteotomy between the maxillary lateral incisors and canines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Osteotomy between the maxillary central incisorsSurgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors. | Procedure or surgery | space between 11/21 |
| Osteotomy between the maxillary lateral incisors and caninesSurgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines | Procedure or surgery | space between 12/13 and 22/23 |
Primary outcome
Bone expansion and dental inclination
Time frame: 1-2 months post-expansion.
Assessment of bone expansion and dental inclination through Cone Beam computed tomography (CBCT) images
3 secondary outcomes
Patient´s perception
Time frame: 2 months post-expansion.
Periodontal effects
Time frame: 2 months post-expansion.
Surgery time
Time frame: During surgery
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 17 Feb 2020.
- Results publication: PubMed 19761925Landes CA, Laudemann K, Petruchin O, Mack MG, Kopp S, Ludwig B, Sader RA, Seitz O. Comparison of bipartite versus tripartite osteotomy for maxillary transversal expansion using 3-dimensional preoperative and postexpansion computed tomography data. J Oral Maxillofac Surg. 2009 Oct;67(10):2287-301. doi: 10.1016/j.joms.2009.04.069.
- Results publication: PubMed 26847514Betts NJ. Surgically Assisted Maxillary Expansion. Atlas Oral Maxillofac Surg Clin North Am. 2016 Mar;24(1):67-77. doi: 10.1016/j.cxom.2015.10.003. Epub 2015 Nov 24. No abstract available.
- Results publication: PubMed 28279603Camps-Pereperez I, Guijarro-Martinez R, Peiro-Guijarro MA, Hernandez-Alfaro F. The value of cone beam computed tomography imaging in surgically assisted rapid palatal expansion: a systematic review of the literature. Int J Oral Maxillofac Surg. 2017 Jul;46(7):827-838. doi: 10.1016/j.ijom.2017.01.017. Epub 2017 Mar 6.
- Individual participant dataSharing planned: No. I plan to share the data on March 24, 2020 when I going to present my Master degrees' thesis. I tried to submit an article with the data. I'm waiting for a reply
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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.
Fabio G Ritto, PhD study chair
Hospital Universitario Pedro Ernesto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteotomy between the maxillary central incisors and Osteotomy between the maxillary lateral incisors and canines in people with Malocclusion and Maxillar Hypoplasia, run by Hospital Universitario Pedro Ernesto 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?
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 17 Feb 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 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?
Bone expansion and dental inclination (time frame: 1-2 months post-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 NCT03503448, which also lists 3 linked publications.
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 17 Feb 2020.