MalocclusionNCT03714087
Occlusal Outcomes by OGS After a Finishing Protocol
A study testing T1 before aligner and T2 after the aligner in people with Malocclusion and Orthodontics, run by Universidad de Antioquia.
Trial summary
Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Orthodontics
- What is being tested?
- T1 before aligner and T2 after the aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to May 2018
- 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 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who completed the active phase of the bimaxillary orthodontic treatment in the Orthodontics Postgraduate Program of the UdeA by criteria of the treating clinician, during 2014 - 2018 period were included. Patients treated by using the UDEA1 finishing protocol (GC) and the UDEA 2 (GE) finishing protocol, which included aligners. All patients must have standardized diagnostic records at the end of the finishing phase (cast models and panoramic X-Rays) and must accepted to participate in the study voluntarily
Who cannot join
- Patients that require prosthetic, periodontal and / or surgical treatments or with systemic compromise that may influence the outcome of orthodontic treatment
About this study
Official title: OGS Scores After the Use of a New Finishing Protocol
Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients
Read the detailed description
Patients who are being treated in the postgraduate orthodontic clinics and who meet the inclusion and exclusion criteria, will be subject to a detailed evaluation according to the OGS criteria and upon meeting the treatment completion criteria they will be placed an aligner with setup for 3 weeks. The scores obtained before and after the aligner will be compared with a historical control group The OGS score obtained for each group, will be compared and the impact of the protocol and the aligner will be evaluated
- Conditions
- Malocclusion, Orthodontics
- Being tested
- T1 before aligner, T2 after the aligner, Historic control group
- Keywords
- Finishing protocol, Aligner
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1 before alignerDevice
The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)
T2 after the alignerOther
The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)
Historic control groupOther
| Study group | Role | What they receive |
|---|---|---|
| T1 Conventional treatment before aligner | Experimental | T1 before aligner: Conventional orthodontic treatment patients before the essix aligner Receives: Device: T1 before aligner |
| T2 After essix aligner | Experimental | T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time Receives: Other: T2 after the aligner |
| Historic control group | Active comparator | Conventional orthodontic treatment without finishing protocol UdeA2 Receives: Other: Historic control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
OGS score
Calculation of the score of the Objective Grading System
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startJul 2014
- Primary completionMar 2018
- Study completionMay 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Carvajal, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714087
- Sponsor's protocol ID
- Finishing2
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OGS Scores After the Use of a New Finishing Protocol
- ClinicalTrials.gov ID
- NCT03714087
- Acronym / sponsor ID
- Finishing2
- Conditions
- Malocclusion, Orthodontics
- Keywords
- Finishing protocol, Aligner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 22 Oct 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.
Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients
Detailed description
Patients who are being treated in the postgraduate orthodontic clinics and who meet the inclusion and exclusion criteria, will be subject to a detailed evaluation according to the OGS criteria and upon meeting the treatment completion criteria they will be placed an aligner with setup for 3 weeks. The scores obtained before and after the aligner will be compared with a historical control group The OGS score obtained for each group, will be compared and the impact of the protocol and the aligner will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)
| Arm | Type | Receives |
|---|---|---|
| T1 Conventional treatment before aligner | Experimental | Device: T1 before alignerT1 before aligner: Conventional orthodontic treatment patients before the essix aligner |
| T2 After essix aligner | Experimental | Other: T2 after the alignerT2 after the aligner: Essix aligner appliance with setup for 3 weeks full time |
| Historic control group | Active comparator | Other: Historic control groupConventional orthodontic treatment without finishing protocol UdeA2 |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who completed the active phase of the bimaxillary orthodontic treatment in the Orthodontics Postgraduate Program of the UdeA by criteria of the treating clinician, during 2014 - 2018 period were included. Patients treated by using the UDEA1 finishing protocol (GC) and the UDEA 2 (GE) finishing protocol, which included aligners. All patients must have standardized diagnostic records at the end of the finishing phase (cast models and panoramic X-Rays) and must accepted to participate in the study voluntarily
Key exclusion criteria (1 listed)
- Patients that require prosthetic, periodontal and / or surgical treatments or with systemic compromise that may influence the outcome of orthodontic treatment
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 |
|---|---|---|
| T1 before alignerThe UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up) | Device | T1 Conventional treatment before aligner |
| T2 after the alignerThe UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up) | Other | T2 After essix aligner |
| Historic control group | Other | Historic control group |
Primary outcome
OGS score
Time frame: Through study completion, an average of 2 year
Calculation of the score of the Objective Grading System
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 22 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing T1 before aligner and T2 after the aligner in people with Malocclusion and Orthodontics, run by Universidad de Antioquia.
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 1 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 22 Oct 2018. 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?
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?
OGS score (time frame: Through study completion, an average of 2 year). 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 22 Oct 2018.