Status:
UNKNOWN
Study to Compare Two Functional Appliances for Class II Malocclusions
Lead Sponsor:
University of Birmingham
Conditions:
Malocclusion, Angle Class II
Eligibility:
All Genders
10-14 years
Phase:
NA
Brief Summary
A randomised controlled clinical trial to compare the effectiveness of two functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite ...
Detailed Description
Background: A functional appliance is a type of brace used to help correct a 'Class II' malocclusion. Class II malocclusions are where upper front teeth bite significantly further forward in relation...
Eligibility Criteria
Inclusion
- \* Overjet ≥ 7mm
- The normal overjet for a Caucasian population is in the range of 2-4mm. A functional appliance is used to allow for overjet reduction without extractions and/or to reduce the anchorage demands of the subsequent treatment with the Straight Wire Appliance (SWA). Clinically the overjet would need to be significantly increased for the treating clinician to consider the use of a functional appliance. Other similar studies have used an overjet of \>6mm or ≥ 7mm. This study has elected for an initial overjet of ≥ 7mm to improve the studies external validity by making it more applicable to day-to-day clinical practice.
- The initial overjet will be used to select patients. The majority of recent high level trials and systematic reviews that have provided a significant amount of the evidence base in the treatment of Class II malocclusions have defined subjects according to their initial overjet.
- \* Age 10 to 14 years
- This has been selected to match other studies relating to functional appliance treatment and reflect the most common clinical practice. The literature on functional appliance treatment has provided evidence that on average the enhancement of growth is small. Some studies on the timing of functional appliance treatment have suggested that pubertal growth is not a significant factor in the success of functional appliance treatment but it is well know and accepted that functional appliance treatment is assisted during periods of more rapid growth. Numerous studies have also found better co-operation and completion of treatment in younger patients (Banks 2004, KOB 2003a \& 2003b)
- \* Satisfactory Dental health
- Patients must be dentally healthy and have a suitable level of oral health that would support orthodontic treatment, as per the British Orthodontic Society guidelines. They must have good oral hygiene with minimal gingivitis or periodontal disease, no dental caries or periapical pathology and no history of dento-alveolar trauma. This is judged by the investigator.
- Willing to participate in study and provide informed consent
Exclusion
- \* No previous orthodontic treatment or premolar extractions
- This is aimed at reducing any confounding factors within the study as these may affect the success of treatment.
- \* No craniofacial syndrome (including Cleft patients)
- This is aimed at reducing any confounding factors within the study as these conditions may affect the success of treatment. The treatment of this subgroup requires a multi-disciplinary team and is more complex. Their treatment pathway may vary from normal clinical practice.
Key Trial Info
Start Date :
July 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03773783
Start Date
July 10 2017
End Date
July 1 2020
Last Update
December 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham dental hospital
Birmingham, United Kingdom