Malocclusion, Angle Class IINCT04875104
Upper Sequential Distalization With TADs and Aligners
A study testing Orthodontic treatment with Invisalign system, Orthodontic treatment with Spark system and Orthodontic treatment with Quicksmile system in people with Malocclusion, Angle Class II and Distalization, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malocclusion, Angle Class II, Distalization
- What is being tested?
- Orthodontic treatment with Invisalign system, Orthodontic treatment with Spark system and Orthodontic treatment with Quicksmile system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2021to Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who needed orthodontic treatment with aligners in both jaws.
- Adult patients (>18 years)
- Full permanent dentition (excluding third molars)
- Patients with non-surgical or non-extraction (excluding third molars) treatment
- No active periodontal disease
- Patients with class II molar relationship that needed molar distalization
Who cannot join
- Patients with systemic diseases affecting bone metabolism or teeth or inflammatory diseases
- Patients undergoing treatment with immunosuppressant or bisphosphonates
- Patients undergoing chemo and radiotherapy
- Patients with any other syndrome-associated orofacial deformation, cleft lip or palate
- Pregnant women or non(or poor)-compliance patients with skeletal discrepancies
- Patients with dental or skeletal crossbite that need 3 mm or more per side of expansion
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, 28040
Carmen García Marín, phd student, 913941979, carmeg06@ucm.es
About this study
Official title: A Randomized Clinical Trial on Upper Sequential Distalization With Temporary Anchorage Devices (TADs) and Two Aligner Systems
In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems. The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems.
Read the detailed description
In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase. Also, the investigators are going to study another dental movements, pain level, aligner properties, oral hygiene, posterior root resorption, patient satisfaction, quality of life and efficiency of these systems.
The aligner systems that are going to be used are Invisalign System (Align Technology, San José, CA), Spark Aligners (Ormco, Glendora, CA), Quicksmile (Madrid, España) and ClearCorrect (Straumann, Austin, TX). To help achieve the molar movement there is going to be place a TAD (temporary anchorage device) between two teeth. Before starting the study, the patients will need some pretreatment records (radiographs, photographs, dental casts and intraoral scan) to make a diagnosis and confirm if the patient is suitable for the study.
The required sample will be 98 subjects, assuming a sample loss of 15% the required sample will be 115 subjects per group. Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study. Data normality will be examined with the Kolmogorov-Smirnov. Descriptive statistics of the different outcomes will be calculated for each group. Student's paired sample t-test will be used to analyze intragroup differences between T0 and T1. Intergroup comparison among different intervention groups will be performed using multiple analysis of variance (MANOVA), with Tukey's post-hoc test. The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age. The investigators will perform a binary logistic regression in order to assess the influence of confounding factor (clinical variables) on the primary outcome. All statistical analysis will be conducted using IBM SPSS 24.0 (SPSS Inc., Chicago, IL, USA) software with a 0.05 level of significance.
- Conditions
- Malocclusion, Angle Class II, Distalization
- Being tested
- Orthodontic treatment with Invisalign system, Orthodontic treatment with Spark system, Orthodontic treatment with Quicksmile system, Orthodontic treatment with ClearCorrect system
- Keywords
- Dentistry, Orthodontics, Clear aligner therapy, Aligners, Invisalign, Upper molar distalization, Temporary anchorage devices, Mini-screws
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic treatment with Invisalign systemDevice
Patients are going to receive an orthodontic treatment with Invisalign aligners.
Orthodontic treatment with Spark systemDevice
Patients are going to receive an orthodontic treatment with Spark aligners.
Orthodontic treatment with Quicksmile systemDevice
Patients are going to receive an orthodontic treatment with Quicksmile aligners.
Orthodontic treatment with ClearCorrect systemDevice
Patients are going to receive an orthodontic treatment with ClearCorrect aligners.
| Study group | Role | What they receive |
|---|---|---|
| Invisalign | Active comparator | Patients treated with Invisalign aligners Receives: Device: Orthodontic treatment with Invisalign system |
| Spark | Experimental | Patients treated with Spark aligners Receives: Device: Orthodontic treatment with Spark system |
| Quicksmile | Experimental | Patients treated with Quicksmile aligners Receives: Device: Orthodontic treatment with Quicksmile system |
| ClearCorrect | Experimental | Patients treated with ClearCorrect aligners Receives: Device: Orthodontic treatment with ClearCorrect system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictability of upper molar distalization
Predictability of upper molar distalization will be assessed in mm comparing pre- and post-distalization 3D models. Pre-treatment 3D model (ModT0) will be superimposed with ideal end of distalization model (ClinT1) and real end of distalization models to see how much distalization has been achieved. The predictability will be the difference between the achieved and the expected amount of tooth movement and to quantify distalization measurements are going to be made in various views and teeth.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Achievement of molar class I
Achievement of class I after distalization will be assessed with yes (=1) or no (=0). It will be considered class I when the mesiobuccal cusp of the upper first molar occludes with the mesiobuccal groove of the lower first molar when seeing models in occlusion with a discrepancy of 0.5 mm.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Secondary outcomes (18)
Individual tooth movement
Individual tooth movement will be evaluated comparing pre- and post distalization 3D models. In the same superposition procedure explained in the previous section, we are going to study the individual movements of the teeth to see where and which movements have not been achieved. And, the difference between the achieved and the expected amount of tooth movement was calculated. We will quantify the accuracy of each individual movement and we will obtain an index of the accuracy of each movement and the movement will be more precise when the value is closer to 1.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Periodontal mucosa health status - Plaque Index (PI)
Periodontal health status measurements will be made on the right maxillary first molar, premolar and central incisor before treatment and after one, three and six months during treatment in both aligner systems. To assess plaque index (PI) the accumulation of plaque will be visually inspected in the gingival area and will be classified on a score of 0 to 3 of the modified index of Löe, where 0 will be "no plaque on inspection/probing" and 3 will be "presence of a thick layer of plaque".
Measured: Time 0 (initial day of treatment), month 3 and month 6
Periodontal mucosa health status - Gingival Index (GI)
Periodontal health status measurements will be made on the right maxillary first molar, premolar and central incisor before treatment and after one, three and six months during treatment in both aligner systems. Color and tissue consistency will be evaluated according to the severity of the inflammation of the gingival margin and will be classified on a score of 0 to 3 of the modified index of Löe, were 0 is "Physiologic gingiva" and 3 is "severe inflammation".
Measured: Time 0 (initial day of treatment), month 3 and month 6
Periodontal mucosa health status - Papillary Bleeding Index (PBI)
Periodontal health status measurements will be made on the right maxillary first molar, premolar and central incisor before treatment and after one, three and six months during treatment in both aligner systems. The PBI will be assessed by inserting a periodontal probe into the gingival sulcus of those three teeth and waiting 20 seconds after probing and will be classified on a score of 0 to 3 of the modified index of Löe, were 0 is "no bleeding" and 3 is "profuse bleeding".
Measured: Time 0 (initial day of treatment), month 3 and month 6
Peri-implant mucosa inflammation
Peri-implant mucosa health status will be also assessed as a reaction of pressure around the TAD with a periodontal probe and registering bleeding with Absence=0 or Presence=1.
Measured: Time 0 (initial day of treatment), month 3 and month 6
TADs stability
Stability will be evaluated in each appointment with cotton tweezers and there will be two groups: mobile (yes=1) and not mobile (no=1). TAD failure will be considered when the implant loosened before or during completion of its use, when it presents mobility or pain on percussion.
Measured: Time 0 (initial day of treatment), month 3 and month 6
Quantification of the modulus of elasticity
Modulus of elasticity measures resistance to being deformed elastically when a stress is applied to it. This will be evaluated on samples cut out from as-received aligners and on aligners after two weeks of use with instrumented indentation testing using a universal testing machine.
Measured: Time 0 (initial day of treatment) and week 2
Quantification of changes in force after 75 desinsertion cycles
The desinsertion force is the force that it is necessary to remove the aligners from de teeth (N). This will be evaluated in vitro in the first passive aligner after being subjected to 75 cycles of insertion/desinsertion of its stereolithographic using a universal testing machine.
Measured: Time 0 (initial day of treatment) and week 2
Quantification of changes in desinsertion time after 75 desinsertion cycles
The desinsertion time is the time that it is necessary to remove the aligners from de teeth (s). This will be evaluated in vitro in the first passive aligner after being subjected to 75 cycles of insertion/desinsertion of its stereolithographic using a universal testing machine.
Measured: Time 0 (initial day of treatment) and week 2
Quantification of changes in deformation after 75 desinsertion cycles
The deformation of the aligner is the amount of deformation that an aligner undergoes when it is removed (mm). This will be evaluated in vitro in the first passive aligner after being subjected to 75 cycles of insertion/desinsertion of its stereolithographic using a universal testing machine.
Measured: Time 0 (initial day of treatment) and week 2
Quantification of the aligner fit on the attachments
The aligner fit is the distance between the internal surface of the aligner and the teeth or attachments. This is use to study the gap between the aligners and the teeth. This will be evaluated in vitro in the passives aligners as-received and after being subjected to 75 cycles of insertion/desinsertion of its stereolithographic using a universal testing machine.
Measured: Time 0 (initial day of treatment) and week 2
Orthodontically induced external apical root resorption (OIEARR)
OIEARR will be measured on upper posterior teeth root lengths before and after distalization with the use of panoramic radiographs. They were divided into two groups (presence>2mm/absence<2mm).
Measured: Time 0 (initial day of treatment) and month 6
Quantification of pain level
Pain level will be assessed using a 0-10 numerical pain rating scale where 0 is "no pain" and 10 is "worst possible pain". They will also be asked some questions regarding pain evaluation and finally, their analgesic consumption, type and frequency. They have to be completed each day during the third week, in week 7 and 11.
Measured: Week 3, week 7 and week 11.
Quantification of quality of life (OHIP-14sp)
Quality of life will be evaluated with the Spanish version of the Oral Health Impact Profile-14 (OHIP-14sp). It is a 14 item questionnaire in which participants have to respond a 5-point Likert scale coded for: never (0), hardly ever (1), occasionally (2), fairly often (3) and very often (4). The overall OHIP-14sp outcome will be obtained by summing the items and so the score ranges from 0 to 56 and the higher the score the higher the lever of oral quality of life and vice versa.
Measured: Time 0 (initial day of treatment) and month 1
Quantification of patient satisfaction (DSQ)
Dental Satisfaction Questionnaire (DSQ) will be used to study patient satisfaction. It has 19 items with a Likert scale from 1 to 5, were 1 is "agree completely", 2 "agree", 3 "undecided", 4 "disagree" and 5 "disagree completely". Agree completely responses were rated with 5 points and disagree completely with 1. The overall outcome will be obtained by summing the items and so the score ranges from 19 to 95, having into account that items 1, 3, 4, 5, 8, 11, 13 and 17 are reverse scored. The higher the score the higher the level of patient satisfaction and vice versa.
Measured: Time 0 (initial day of treatment) and month 1
Quantification of the treatment and chair time.
Distalization treatment time will be measured in months and days since the first aligner is delivered to the patient until the last day of distalization of the first premolar. It should be taken into consideration the mid-course corrections if necessary.
Chair time of each scheduled or non-scheduled appointment is the total time that the patient spends in the dental chair regardless of the interaction with the doctor or assistant. Treatment time in minutes will be estimated with a stopwatch and rounded up to the nearest 30 seconds.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Quantification of the number of appointments.
Total number of appointments, emergency visits related to the appliances and cancellations will be also noted. Regarding the emergency visits the reason will be noted, attachment debonding, damage or loss of the aligners or other reasons related with the TADs.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Quantification of the direct and indirect costs.
Direct costs (Euros) in this study included material costs and treatment time needed. Indirect costs (Euros) will be defined as loss of income, assuming that the patients will be absent from work during the orthodontic appointment.
Measured: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Model description
- This study will be a 4-arm parallel-group, randomized, prospective superiority clinical trial with an allocation ratio of 1:1:1:1 There will be four groups of aligners of different brands.
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Iglesias Linares, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875104
- Sponsor's protocol ID
- URI 39-150221
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We have not yet decided the format in which to share the information.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Upper Sequential Distalization With Temporary Anchorage Devices (TADs) and Two Aligner Systems
- ClinicalTrials.gov ID
- NCT04875104
- Acronym / sponsor ID
- URI 39-150221
- Conditions
- Malocclusion, Angle Class II, Distalization
- Keywords
- Dentistry, Orthodontics, Clear aligner therapy, Aligners, Invisalign, Upper molar distalization, Temporary anchorage devices, Mini-screws
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 May 2021 (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.
In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems. The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems.
Detailed description
In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase. Also, the investigators are going to study another dental movements, pain level, aligner properties, oral hygiene, posterior root resorption, patient satisfaction, quality of life and efficiency of these systems.
The aligner systems that are going to be used are Invisalign System (Align Technology, San José, CA), Spark Aligners (Ormco, Glendora, CA), Quicksmile (Madrid, España) and ClearCorrect (Straumann, Austin, TX). To help achieve the molar movement there is going to be place a TAD (temporary anchorage device) between two teeth. Before starting the study, the patients will need some pretreatment records (radiographs, photographs, dental casts and intraoral scan) to make a diagnosis and confirm if the patient is suitable for the study.
The required sample will be 98 subjects, assuming a sample loss of 15% the required sample will be 115 subjects per group. Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study. Data normality will be examined with the Kolmogorov-Smirnov. Descriptive statistics of the different outcomes will be calculated for each group. Student's paired sample t-test will be used to analyze intragroup differences between T0 and T1. Intergroup comparison among different intervention groups will be performed using multiple analysis of variance (MANOVA), with Tukey's post-hoc test. The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age. The investigators will perform a binary logistic regression in order to assess the influence of confounding factor (clinical variables) on the primary outcome. All statistical analysis will be conducted using IBM SPSS 24.0 (SPSS Inc., Chicago, IL, USA) software with a 0.05 level of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study will be a 4-arm parallel-group, randomized, prospective superiority clinical trial with an allocation ratio of 1:1:1:1 There will be four groups of aligners of different brands.
| Arm | Type | Receives |
|---|---|---|
| Invisalign | Active comparator | Device: Orthodontic treatment with Invisalign systemPatients treated with Invisalign aligners |
| Spark | Experimental | Device: Orthodontic treatment with Spark systemPatients treated with Spark aligners |
| Quicksmile | Experimental | Device: Orthodontic treatment with Quicksmile systemPatients treated with Quicksmile aligners |
| ClearCorrect | Experimental | Device: Orthodontic treatment with ClearCorrect systemPatients treated with ClearCorrect aligners |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who needed orthodontic treatment with aligners in both jaws.
- Adult patients (>18 years)
- Full permanent dentition (excluding third molars)
- Patients with non-surgical or non-extraction (excluding third molars) treatment
- No active periodontal disease
Key exclusion criteria (6 listed)
- Patients with systemic diseases affecting bone metabolism or teeth or inflammatory diseases
- Patients undergoing treatment with immunosuppressant or bisphosphonates
- Patients undergoing chemo and radiotherapy
- Patients with any other syndrome-associated orofacial deformation, cleft lip or palate
- Pregnant women or non(or poor)-compliance patients with skeletal discrepancies
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 |
|---|---|---|
| Orthodontic treatment with Invisalign systemPatients are going to receive an orthodontic treatment with Invisalign aligners. | Device | Invisalign |
| Orthodontic treatment with Spark systemPatients are going to receive an orthodontic treatment with Spark aligners. | Device | Spark |
| Orthodontic treatment with Quicksmile systemPatients are going to receive an orthodontic treatment with Quicksmile aligners. | Device | Quicksmile |
| Orthodontic treatment with ClearCorrect systemPatients are going to receive an orthodontic treatment with ClearCorrect aligners. | Device | ClearCorrect |
Primary outcome
Predictability of upper molar distalization
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Predictability of upper molar distalization will be assessed in mm comparing pre- and post-distalization 3D models. Pre-treatment 3D model (ModT0) will be superimposed with ideal end of distalization model (ClinT1) and real end of distalization models to see how much distalization has been achieved. The predictability will be the difference between the achieved and the expected amount of tooth movement and to quantify distalization measurements are going to be made in various views and teeth.
Achievement of molar class I
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Achievement of class I after distalization will be assessed with yes (=1) or no (=0). It will be considered class I when the mesiobuccal cusp of the upper first molar occludes with the mesiobuccal groove of the lower first molar when seeing models in occlusion with a discrepancy of 0.5 mm.
18 secondary outcomes
Individual tooth movement
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Periodontal mucosa health status - Plaque Index (PI)
Time frame: Time 0 (initial day of treatment), month 3 and month 6
Periodontal mucosa health status - Gingival Index (GI)
Time frame: Time 0 (initial day of treatment), month 3 and month 6
Periodontal mucosa health status - Papillary Bleeding Index (PBI)
Time frame: Time 0 (initial day of treatment), month 3 and month 6
Peri-implant mucosa inflammation
Time frame: Time 0 (initial day of treatment), month 3 and month 6
TADs stability
Time frame: Time 0 (initial day of treatment), month 3 and month 6
Quantification of the modulus of elasticity
Time frame: Time 0 (initial day of treatment) and week 2
Quantification of changes in force after 75 desinsertion cycles
Time frame: Time 0 (initial day of treatment) and week 2
Quantification of changes in desinsertion time after 75 desinsertion cycles
Time frame: Time 0 (initial day of treatment) and week 2
Quantification of changes in deformation after 75 desinsertion cycles
Time frame: Time 0 (initial day of treatment) and week 2
Quantification of the aligner fit on the attachments
Time frame: Time 0 (initial day of treatment) and week 2
Orthodontically induced external apical root resorption (OIEARR)
Time frame: Time 0 (initial day of treatment) and month 6
Quantification of pain level
Time frame: Week 3, week 7 and week 11.
Quantification of quality of life (OHIP-14sp)
Time frame: Time 0 (initial day of treatment) and month 1
Quantification of patient satisfaction (DSQ)
Time frame: Time 0 (initial day of treatment) and month 1
Quantification of the treatment and chair time.
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Quantification of the number of appointments.
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Quantification of the direct and indirect costs.
Time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: Undecided. We have not yet decided the format in which to share the information.
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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.
Alejandro Iglesias Linares study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic treatment with Invisalign system, Orthodontic treatment with Spark system and Orthodontic treatment with Quicksmile system in people with Malocclusion, Angle Class II and Distalization, run by Universidad Complutense de Madrid at 1 site in Spain.
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 6 inclusion and 6 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 4 Nov 2021. 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 Spain. 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 Carmen García Marín, Phd student (913941979, carmeg06@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictability of upper molar distalization (time frame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)). The study lists 2 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 4 Nov 2021.