Malocclusion, Angle Class IINCT05853211
Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns
An observational study of Malocclusion, Angle Class II, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Aligner and inter-arch elastics
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2024to 1 Oct 2024
- Phase
- Observational
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult with class II malocclusion treated with class II elastics
Who may be able to join
- CVM stage 5 on lateral teleradiography (end of growth)
- Angle Class II
- Treatments with rubber bands for inter-arch traction
- End of treatment in class I
Who cannot join
- Incomplete data
- Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
- Dental agenesis (excluding wisdom teeth)
- Cranial-facial syndromes
Trial locations and contacts
1 site in 1 country.
France1 site
DEON
Nancy, Lorraine, 54000
Lou DEON, Student, +33685327891, loudeon@yahoo.fr
About this study
Official title: Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns in Adult Patients: Retrospective Study.
The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.
Read the detailed description
It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Aligner and inter-arch elastics
- Keywords
- aligner, inter-arch elastic, orthodontic, class II malocclusion, adult, clear aligner, orthodontic appliance, Invisalign, class II elastics, angle class II malocclusion
- Medical subject headings
- Malocclusion, Angle Class II, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aligner and inter-arch elasticsCombination product
Correction of class II malocclusion by class II elastics on clear aligners
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner | Patient with class II malocclusion, treated with class II elastics on aligners Receives: Combination Product: Aligner and inter-arch elastics | |
| Fixed appliance | Patient with class II malocclusion, treated with class II elastics on fixed appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IMPA Mandibular incisor angle (degrees)
Angle between the mandibular plane and the lower incisor axis: position of the lower incisor in relation to the mandible
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.
Secondary outcomes (24)
Sex
Sex
Measured: 1 month
Duration of treatment
Treatment time duration in month
Measured: 24 months
Change in interproximal dental size
Interproximal size in mm
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern ANB angle
Cephalometric measurements : angle between A, Na (nasion) and B in degrees
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern Ao-Bo
Cephalometric measurements : mesure in mm between Ao and Bo
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : FMA
Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : Sn Gogn
Cephalometric measurements : angle in degrees between SN and GoGn
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale anterior height
Cephalometric measurements of faciale anterior height
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale posterior height
Cephalometric measurements of faciale posterior height
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in index Faciale height
Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height)
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in nterincisal angle
Cephalometric measurements : measurement between manxillary and mandibular incisors.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in plan of occlusion
Cephalometric measurements : angle between SN and Op
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Age at the beginning of treatment
Age
Measured: 1 month
Age at the end of treatment
Age
Measured: 24 months
Change in von Spee curve
Measurements on impressions : it is the average of the distance between the highest point of the deepest cusp and the occlusal plane.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overall crowding
Measurements on impressions : comparison of the sum of the mesiodistal diameters of 35 to 45 and the arch perimeter from the mesial face of 36 to the mesial face of 46.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overjet
Measurements on impressions : in mm
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overbite
Measurements on impressions : in mm
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in arch length
Measurements on impressions : distance between inter incisal point and mesiale face of 6.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
CHange in class II quantity
Measurements on impressions : inter canine and inter molar relations
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in space required
Measurements on impressions : sum of all mesiodistal diameter.
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter canine distance
Measurements on impressions : distance between the canine in mm
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter premolar distance
Measurements on impressions : distance between the premolars
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter molar distance
Measurements on impressions : distance between the molars
Measured: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start30 Sep 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANDE VANNET Bart, Central Hospital, Nancy, France
- Investigators
- Bart VANDE VANNET, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853211
- Sponsor's protocol ID
- 2023PI022
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Janson G, Sathler R, Fernandes TM, Branco NC, Freitas MR. Correction of Class II malocclusion with Class II elastics: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):383-92. doi: 10.1016/j.ajodo.2012.10.015.
PubMed 23452973Robertson L, Kaur H, Fagundes NCF, Romanyk D, Major P, Flores Mir C. Effectiveness of clear aligner therapy for orthodontic treatment: A systematic review. Orthod Craniofac Res. 2020 May;23(2):133-142. doi: 10.1111/ocr.12353. Epub 2019 Nov 13.
PubMed 31651082Zheng M, Liu R, Ni Z, Yu Z. Efficiency, effectiveness and treatment stability of clear aligners: A systematic review and meta-analysis. Orthod Craniofac Res. 2017 Aug;20(3):127-133. doi: 10.1111/ocr.12177. Epub 2017 May 26.
PubMed 28547915Lombardo L, Colonna A, Carlucci A, Oliverio T, Siciliani G. Class II subdivision correction with clear aligners using intermaxilary elastics. Prog Orthod. 2018 Sep 1;19(1):32. doi: 10.1186/s40510-018-0221-5.
PubMed 30171391Dianiskova S, Rongo R, Buono R, Franchi L, Michelotti A, D'Anto V. Treatment of mild Class II malocclusion in growing patients with clear aligners versus fixed multibracket therapy: A retrospective study. Orthod Craniofac Res. 2022 Feb;25(1):96-102. doi: 10.1111/ocr.12500. Epub 2021 May 31.
PubMed 34013659Duncan LO, Piedade L, Lekic M, Cunha RS, Wiltshire WA. Changes in mandibular incisor position and arch form resulting from Invisalign correction of the crowded dentition treated nonextraction. Angle Orthod. 2016 Jul;86(4):577-83. doi: 10.2319/042415-280.1. Epub 2015 Dec 4.
PubMed 26636248Amm E, El Amm C, Vaden J. Effect of Class II elastics on different mandibular arch preparation stabilized with aligners and stainless-steel wires: A FEM study. Orthod Craniofac Res. 2022 Nov;25(4):520-529. doi: 10.1111/ocr.12564. Epub 2022 Jan 27.
PubMed 35015923Rongo R, Dianiskova S, Spiezia A, Bucci R, Michelotti A, D'Anto V. Class II Malocclusion in Adult Patients: What Are the Effects of the Intermaxillary Elastics with Clear Aligners? A Retrospective Single Center One-Group Longitudinal Study. J Clin Med. 2022 Dec 9;11(24):7333. doi: 10.3390/jcm11247333.
PubMed 36555949Deregibus A, Tallone L, Rossini G, Parrini S, Piancino M, Castroflorio T. Morphometric analysis of dental arch form changes in class II patients treated with clear aligners. J Orofac Orthop. 2020 Jul;81(4):229-238. doi: 10.1007/s00056-020-00224-8. Epub 2020 Apr 14.
PubMed 32291482Liu X, Cheng Y, Qin W, Fang S, Wang W, Ma Y, Jin Z. Effects of upper-molar distalization using clear aligners in combination with Class II elastics: a three-dimensional finite element analysis. BMC Oral Health. 2022 Dec 1;22(1):546. doi: 10.1186/s12903-022-02526-2.
PubMed 36456944Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
PubMed 12169031Marshall SD, Caspersen M, Hardinger RR, Franciscus RG, Aquilino SA, Southard TE. Development of the curve of Spee. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):344-52. doi: 10.1016/j.ajodo.2006.10.037.
PubMed 18774080Fawaz P, Amm E, Khoury E. The curve of Spee and its levelling in different vertical skeletal patterns: A 3D set-up study. Int Orthod. 2021 Dec;19(4):659-668. doi: 10.1016/j.ortho.2021.08.003. Epub 2021 Aug 31.
PubMed 34479824Adel SM, Vaid NR, El-Harouni N, Kassem H, Zaher AR. Digital model superimpositions: are different software algorithms equally accurate in quantifying linear tooth movements? BMC Oral Health. 2022 Mar 31;22(1):103. doi: 10.1186/s12903-022-02129-x.
PubMed 35361187
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns in Adult Patients: Retrospective Study.
- ClinicalTrials.gov ID
- NCT05853211
- Acronym / sponsor ID
- 2023PI022
- Conditions
- Malocclusion, Angle Class II
- Keywords
- aligner, inter-arch elastic, orthodontic, class II malocclusion, adult, clear aligner, orthodontic appliance, Invisalign
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 May 2023 (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.
The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.
Detailed description
It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner | – | Combination Product: Aligner and inter-arch elasticsPatient with class II malocclusion, treated with class II elastics on aligners |
| Fixed appliance | – | –Patient with class II malocclusion, treated with class II elastics on fixed appliance |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult with class II malocclusion treated with class II elastics
Key inclusion criteria (4 listed)
- CVM stage 5 on lateral teleradiography (end of growth)
- Angle Class II
- Treatments with rubber bands for inter-arch traction
- End of treatment in class I
Key exclusion criteria (4 listed)
- Incomplete data
- Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
- Dental agenesis (excluding wisdom teeth)
- Cranial-facial syndromes
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 |
|---|---|---|
| Aligner and inter-arch elasticsCorrection of class II malocclusion by class II elastics on clear aligners | Combination product | Clear aligner |
Primary outcome
Change in IMPA Mandibular incisor angle (degrees)
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.
Angle between the mandibular plane and the lower incisor axis: position of the lower incisor in relation to the mandible
24 secondary outcomes
Sex
Time frame: 1 month
Duration of treatment
Time frame: 24 months
Change in interproximal dental size
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern ANB angle
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal sagittal pattern Ao-Bo
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : FMA
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : Sn Gogn
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale anterior height
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale posterior height
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in index Faciale height
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in nterincisal angle
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in plan of occlusion
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Age at the beginning of treatment
Time frame: 1 month
Age at the end of treatment
Time frame: 24 months
Change in von Spee curve
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overall crowding
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overjet
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overbite
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in arch length
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
CHange in class II quantity
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in space required
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter canine distance
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter premolar distance
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter molar distance
Time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 23452973Janson G, Sathler R, Fernandes TM, Branco NC, Freitas MR. Correction of Class II malocclusion with Class II elastics: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):383-92. doi: 10.1016/j.ajodo.2012.10.015.
- Background: PubMed 31651082Robertson L, Kaur H, Fagundes NCF, Romanyk D, Major P, Flores Mir C. Effectiveness of clear aligner therapy for orthodontic treatment: A systematic review. Orthod Craniofac Res. 2020 May;23(2):133-142. doi: 10.1111/ocr.12353. Epub 2019 Nov 13.
- Background: PubMed 28547915Zheng M, Liu R, Ni Z, Yu Z. Efficiency, effectiveness and treatment stability of clear aligners: A systematic review and meta-analysis. Orthod Craniofac Res. 2017 Aug;20(3):127-133. doi: 10.1111/ocr.12177. Epub 2017 May 26.
- Background: PubMed 30171391Lombardo L, Colonna A, Carlucci A, Oliverio T, Siciliani G. Class II subdivision correction with clear aligners using intermaxilary elastics. Prog Orthod. 2018 Sep 1;19(1):32. doi: 10.1186/s40510-018-0221-5.
- Background: PubMed 34013659Dianiskova S, Rongo R, Buono R, Franchi L, Michelotti A, D'Anto V. Treatment of mild Class II malocclusion in growing patients with clear aligners versus fixed multibracket therapy: A retrospective study. Orthod Craniofac Res. 2022 Feb;25(1):96-102. doi: 10.1111/ocr.12500. Epub 2021 May 31.
- Background: PubMed 26636248Duncan LO, Piedade L, Lekic M, Cunha RS, Wiltshire WA. Changes in mandibular incisor position and arch form resulting from Invisalign correction of the crowded dentition treated nonextraction. Angle Orthod. 2016 Jul;86(4):577-83. doi: 10.2319/042415-280.1. Epub 2015 Dec 4.
- Background: PubMed 35015923Amm E, El Amm C, Vaden J. Effect of Class II elastics on different mandibular arch preparation stabilized with aligners and stainless-steel wires: A FEM study. Orthod Craniofac Res. 2022 Nov;25(4):520-529. doi: 10.1111/ocr.12564. Epub 2022 Jan 27.
- Background: PubMed 36555949Rongo R, Dianiskova S, Spiezia A, Bucci R, Michelotti A, D'Anto V. Class II Malocclusion in Adult Patients: What Are the Effects of the Intermaxillary Elastics with Clear Aligners? A Retrospective Single Center One-Group Longitudinal Study. J Clin Med. 2022 Dec 9;11(24):7333. doi: 10.3390/jcm11247333.
- Background: PubMed 32291482Deregibus A, Tallone L, Rossini G, Parrini S, Piancino M, Castroflorio T. Morphometric analysis of dental arch form changes in class II patients treated with clear aligners. J Orofac Orthop. 2020 Jul;81(4):229-238. doi: 10.1007/s00056-020-00224-8. Epub 2020 Apr 14.
- Background: PubMed 36456944Liu X, Cheng Y, Qin W, Fang S, Wang W, Ma Y, Jin Z. Effects of upper-molar distalization using clear aligners in combination with Class II elastics: a three-dimensional finite element analysis. BMC Oral Health. 2022 Dec 1;22(1):546. doi: 10.1186/s12903-022-02526-2.
- Background: PubMed 12169031Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
- Background: PubMed 18774080Marshall SD, Caspersen M, Hardinger RR, Franciscus RG, Aquilino SA, Southard TE. Development of the curve of Spee. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):344-52. doi: 10.1016/j.ajodo.2006.10.037.
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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.
Bart VANDE VANNET study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, Angle Class II, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 4 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 23 Jul 2024. 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 France. 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 Bart VANDE VANNET, Phd (+32496284339, bart.vande-vannet@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IMPA Mandibular incisor angle (degrees) (time frame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.). 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 NCT05853211, which also lists 14 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 23 Jul 2024.