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

Not yet recruiting

• Conditions: Malocclusion, Angle Class II

• Registration Number: NCT05853211
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

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 Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23
• Study Start: 2024-09-30
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IMPA Mandibular incisor angle (degrees)	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 Outcome Measures

Name	Time	Method
Duration of treatment	24 months	Treatment time duration in month
Sex	1 month	Sex
Change in interproximal dental size	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months	Interproximal size in mm
Change in skeletal sagittal pattern Ao-Bo	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
Change in faciale anterior height	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
Change in von Spee curve	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.
Change in skeletal vertical pattern : Sn Gogn	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
Change in plan of occlusion	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
Age at the beginning of treatment	1 month	Age
Age at the end of treatment	24 months	Age
Change in index Faciale height	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)
Change in nterincisal angle	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.
Change in overbite	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
Change in skeletal sagittal pattern ANB angle	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
Change in skeletal vertical pattern : FMA	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.
Change in arch length	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.
Change in inter premolar distance	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
Change in faciale posterior height	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
Change in overjet	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
Change in inter canine distance	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
Change in overall crowding	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.
CHange in class II quantity	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
Change in space required	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.
Change in inter molar distance	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

Trial Locations

Locations (1)

DEON; 🇫🇷 Nancy, Lorraine, France