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Modified Herbst Approach for Overbite
N/A
Recruiting
Led By Carlos Flores Mir, DSc
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare two orthodontic treatment protocols to see which is more effective. Questions about patient experience will also be asked.
Who is the study for?
This trial is for individuals with a specific dental condition called Class II skeletal malocclusion, where the lower jaw and teeth are significantly behind the upper ones. They should have all permanent teeth and no missing congenital teeth. It's not suitable for those who only qualify for surgical treatment or don't have at least an end-to-end molar relationship.Check my eligibility
What is being tested?
The study compares two orthodontic treatments to correct overbites: one uses the Modified Herbst device followed by braces, while the other adds bone screws before using the Herbst device and then braces. The goal is to see which method better improves chin projection and alignment of teeth.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing devices, soreness in jaws or gums, possible irritation inside mouth from brackets or screws, and temporary changes in speech or chewing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incisor
Oral health-related quality of life
Overall quality of life
+2 moreSecondary outcome measures
Mandibular lip prominence
Lip structure
Upper incisor inclination
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Class II type B malocclusion - proclination of upper incisors not indicated - TADsExperimental Treatment1 Intervention
CA modified hybrid Herbst appliance approach (same hybrid Herbst appliance approach but with the addition of temporary anchorage devices (TADs) in both arches) will be used (alternative treatment). In the upper arch, the TADs would be inserted in the paramedical palatal area. In the lower arch, they would be inserted buccally between the roots of the lower second premolar and the first permanent molar. Elastomeric chains will be used to link these TADs to the first molars in the upper arch and to a buccal bottom on the lower canines.
Group II: Class II type A malocclusion - proclination of upper incisors indicated - TADsExperimental Treatment1 Intervention
A modified hybrid Herbst appliance approach (same hybrid Herbst appliance approach but with the addition of temporary anchorage devices (TADs) in both arches) will be used (alternative treatment). In the upper arch, the TADs would be inserted in the paramedical palatal area. In the lower arch, they would be inserted buccally between the roots of the lower second premolar and the first permanent molar. Elastomeric chains will be used to link these TADs to the first molars in the upper arch and to a buccal bottom on the lower canines. Upper brackets will be initially bonded and upper incisors proclined until normal inclination values are attained.
Group III: Class II type A malocclusion - proclination of upper incisors indicated - No TADsActive Control1 Intervention
A hybrid Herbst appliance approach will be used (current available conventional treatment). The upper jaw component will be a maxillary expander secured on the first molar bands. The lower arch would have an uncemented lower acrylic full-coverage splint-type. In between Herbst-type pistons will be used. Upper brackets will be initially bonded and upper incisors proclined until normal inclination values are attained.
Group IV: Class II type B malocclusion - proclination of upper incisors not indicated - No TADsActive Control1 Intervention
A hybrid Herbst appliance approach will be used (current available conventional treatment). The upper jaw component will be a maxillary expander secured on the first molar bands. The lower arch would have an uncemented lower acrylic full-coverage splint-type. In between Herbst-type pistons will be used.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,137 Total Patients Enrolled
1 Trials studying Overbite
4 Patients Enrolled for Overbite
Carlos Flores Mir, DScPrincipal InvestigatorUniversity of Alberta
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must I meet to be eligible for this research endeavor?
"To be eligible for this project, the patient must have an overbite and should fall within the 12 to 15 year old demographic. Approximately 40 participants will be accepted into this trial."
Answered by AI
Is it still possible to join this clinical trial?
"The trial, originally published on August 25th 2023 is currently looking for new participants. Clinicaltrials.gov has recently refreshed the information regarding this study to reflect changes that were made as of October 3rd 2023."
Answered by AI
Does this study include individuals aged 30 and over?
"According to the entry requirements, individuals wishing to participate must be between 12 and 15 years old. There are 38 studies for people younger than 18 and 8 for those above 65 years of age."
Answered by AI
How many participants are being invited to take part in this research?
"Affirmative. Data available on clinicaltrials.gov verifies that this medical trial, initially posted on August 25th 2023, is currently recruiting participants. The study requires 40 individuals to be enrolled at 1 designated site."
Answered by AI
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