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NCT Number: NCT05853211

Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns

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.

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Overbite Stomatognathic Diseases Tooth Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Incomplete data
  • Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
  • Dental agenesis (excluding wisdom teeth)
  • Cranial-facial syndromes

Treatment and study plan

Aligner and inter-arch elastics

Combination Product

Correction of class II malocclusion by class II elastics on clear aligners

Primary outcomes

  1. 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

Secondary outcomes

  1. Sex

    Time frame: 1 month

    Sex

  2. Duration of treatment

    Time frame: 24 months

    Treatment time duration in month

  3. 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

    Interproximal size in mm

  4. 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

    Cephalometric measurements : angle between A, Na (nasion) and B in degrees

  5. 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

    Cephalometric measurements : mesure in mm between Ao and Bo

  6. 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

    Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan.

  7. 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

    Cephalometric measurements : angle in degrees between SN and GoGn

  8. 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

    Cephalometric measurements of faciale anterior height

  9. 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

    Cephalometric measurements of faciale posterior height

  10. 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

    Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height)

  11. 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

    Cephalometric measurements : measurement between manxillary and mandibular incisors.

  12. 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

    Cephalometric measurements : angle between SN and Op

  13. Age at the beginning of treatment

    Time frame: 1 month

    Age

  14. Age at the end of treatment

    Time frame: 24 months

    Age

  15. 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

    Measurements on impressions : it is the average of the distance between the highest point of the deepest cusp and the occlusal plane.

  16. 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

    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.

  17. 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

    Measurements on impressions : in mm

  18. 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

    Measurements on impressions : in mm

  19. 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

    Measurements on impressions : distance between inter incisal point and mesiale face of 6.

  20. 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

    Measurements on impressions : inter canine and inter molar relations

  21. 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

    Measurements on impressions : sum of all mesiodistal diameter.

  22. 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

    Measurements on impressions : distance between the canine in mm

  23. 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

    Measurements on impressions : distance between the premolars

  24. 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

    Measurements on impressions : distance between the molars

Study contacts

Contact information is provided by the study sponsor or research team.

Bart VANDE VANNET, Phd

CONTACT

[email protected]

+32496284339

Lou DEON

CONTACT

[email protected]

+33685327891

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns in Adult Patients: Retrospective Study.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 10, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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