Clinical trial NCT04419805: Single Palatal Temporary Anchorage Device for Anterior Open Bite
Official title: Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Openbite
Keywords: Orthodontics
Temporary Anchorage Device
Anterior Open Bite
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised parallel 2 group clinical trial
Primary purpose: TREATMENT

Brief summary: Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs

Detailed description: Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction

Eligibility criteria: Inclusion Criteria:

* Patients with AOB of 1-6mm
* Aged between (12 and 40 years).
* Able to consent.
* Patient due to undergo orthodontic treatment with fixed orthodontic braces.

Exclusion Criteria:

* Patient has previously had upper first permanent molar extraction.
* Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
* Patient with bone disease or taking medications that affect the bone quality or nature.
* Patient with an active digit sucking habit.
* Pregnant or breastfeeding women

Primary outcomes:
measure: Molar intrusion
timeFrame: 9-12 months after treatment commences
Secondary outcomes:
measure: Overbite (vertical overlap of anterior teeth)
timeFrame: 9-12 months after treatment commences
measure: Patient Experience
timeFrame: 9-12 months after treatment commences
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Dundee Dental Hospital
Study officials:
affiliation: University of Dundee
name: Peter Mossey, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076.