Maxillary AnomalyNCT04041804
Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults
A study testing semirapid maxillary expansion (SRME) in people with Maxillary Anomaly, run by Fundación Universitaria CIEO at 1 site in Colombia.
Trial summary
OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Maxillary Anomaly
- What is being tested?
- semirapid maxillary expansion (SRME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2021to Dec 2022
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth
- The needs of maxillary expansion for the correction of their malocclusion
- Age range from 20 to 35
- Non-gingivitis or untreated caries at the start of orthodontic treatment
- Probing depth less than 4mm across the entire dentition
- Gingival index ≤ 1
- Plaque index ≤ 1
Who cannot join
- Increased Monson curve
- Patients with systemic disease
- Patients with congenital anomalies
- Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- Pregnancy
- Poor oral hygiene for more than two visits
Show all 10Show fewer
- Radiographic evidence of moderate to severe bone loss
- Current periodontal disease
- Patients who smoke
- Individuals with inadequately treated endodontic problems in the study area.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Universitaria UniCIEO
Bogotá, DC, 110111
Sonia P Plaza, Msc, 573183973032, sp.plaza@unicieo.edu.co
Elsa Arango, DDs, 573102857936, evarango8@gmail.com
About this study
Official title: Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults
OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.
- Conditions
- Maxillary Anomaly
- Being tested
- semirapid maxillary expansion (SRME)
- Keywords
- Palatal Expansion Technique, Cone-Beam Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semirapid maxillary expansion (SRME)Procedure or surgery
Also called Maxillary Expansion
A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension
| Study group | Role | What they receive |
|---|---|---|
| Every week RPE activation | Active comparator | Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed Receives: Procedure: semirapid maxillary expansion (SRME) |
| Every four days RPE activation | Active comparator | Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed Receives: Procedure: semirapid maxillary expansion (SRME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transversal distance between upper canines, first premolars and upper first molars
Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars
Measured: Change from baseline to 6 months
Posterior teeth buccal inclination
Measure in CBCT in a coronal slice between the palatal plane and the dental axis
Measured: Change from baseline to 6 months
Buccal bone area evaluation
Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars
Measured: Change from baseline to 6 months
Secondary outcomes (5)
Bleeding on probing (BP)
It's going to be measured by clinical exam with a periodontal probe and it is verified the presence of bleeding and it will be register as 0= No bleeding and 1= bleeding
Measured: Change from baseline to 6 months
Evaluation of the perception of pain by the patient (VAS)
Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
Measured: Change from baseline to 6 months
Probing depth (PD)
Probing depth (PD): It's going to be measured by clinical exam with a periodontal probe and it is measured from the gingival margin to the bottom of the groove. It is considered the presence of a periodontal pocket when the depth of the groove is greater than 3mm.
Measured: Change from baseline to 6 months
Clinical attachment level (CAL)
Linear measurement in mm. It is constructed from the relationship between probe depth (PD) and the measurement in millimeters from the cement enamel junction (CEJ) to the gingival margin
Measured: Change from baseline to 6 months
Soft tissue recession (STR)
Soft tissue apical migration of the cement-enamel junction, it is going to classified as:
Class I: Retraction of marginal tissue that does not extend to the mucogingival junction without loss of interdental tissue.
Class II: Retraction of marginal tissue that extends to the mucogingival junction, or beyond it, there is no loss of bone, nor of interdental soft tissue.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startFeb 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary AnomalyStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Patricia Plaza, Fundación Universitaria CIEO
- Investigators
- Elsa Arango, DDS, Study chair, Fundación Universitaria UniCIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041804
- Sponsor's protocol ID
- 044
- Status last verified
- Aug 2020
- First submitted
- 13 Feb 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults
- ClinicalTrials.gov ID
- NCT04041804
- Acronym / sponsor ID
- 044
- Conditions
- Maxillary Anomaly
- Keywords
- Palatal Expansion Technique, Cone-Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Aug 2019 (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.
OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every week RPE activation | Active comparator | Procedure: semirapid maxillary expansion (SRME)Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed |
| Every four days RPE activation | Active comparator | Procedure: semirapid maxillary expansion (SRME)Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth
- The needs of maxillary expansion for the correction of their malocclusion
- Age range from 20 to 35
- Non-gingivitis or untreated caries at the start of orthodontic treatment
- Probing depth less than 4mm across the entire dentition
Key exclusion criteria (10 listed)
- Increased Monson curve
- Patients with systemic disease
- Patients with congenital anomalies
- Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- Pregnancy
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 |
|---|---|---|
| semirapid maxillary expansion (SRME)Also: Maxillary ExpansionA Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension | Procedure or surgery | Every four days RPE activation, Every week RPE activation |
Primary outcome
Transversal distance between upper canines, first premolars and upper first molars
Time frame: Change from baseline to 6 months
Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars
Posterior teeth buccal inclination
Time frame: Change from baseline to 6 months
Measure in CBCT in a coronal slice between the palatal plane and the dental axis
Buccal bone area evaluation
Time frame: Change from baseline to 6 months
Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars
5 secondary outcomes
Bleeding on probing (BP)
Time frame: Change from baseline to 6 months
Evaluation of the perception of pain by the patient (VAS)
Time frame: Change from baseline to 6 months
Probing depth (PD)
Time frame: Change from baseline to 6 months
Clinical attachment level (CAL)
Time frame: Change from baseline to 6 months
Soft tissue recession (STR)
Time frame: Change from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
Elsa Arango, DDS study chair
Fundación Universitaria UniCIEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semirapid maxillary expansion (SRME) in people with Maxillary Anomaly, run by Fundación Universitaria CIEO at 1 site in Colombia.
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 7 inclusion and 10 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 2 Sep 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 Colombia. 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?
Contact Sonia Plaza, MSD (573183973032, orthoplaza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transversal distance between upper canines, first premolars and upper first molars (time frame: Change from baseline to 6 months). The study lists 3 primary outcomes in all. 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 2 Sep 2020.