Britta A. Jung, Heinrich Wehrbein, Werner Hopfenmüller, Winfried Harzer, Tomasz, Gedrange, Peter Diedrich, Martin Kunkel,
Background: In orthodontic treatment, anchorage control is a
fundamental aspect. Usually conventional mechanism for orthodontic anchorage
control can be either extraoral or intraoral that is headgear or intermaxillary
elastics. Their use are combined with various side effects such as tipping of
occlusal plane or undesirable movements of teeth. Especially in cases, where
key-teeth are missing, conventional anchorage defined as tooth-borne anchorage
will meet limitations. Therefore, the use of endosseous implants for anchorage
purposes are increasingly used to achieve positional stability and maximum
anchorage.
Methods/Design: The intended study is designed as a prospective,
multicenter randomized controlled trial (RCT), comparing and contrasting the
effect of early loading of palatal implant therapy versus implant loading after
12 weeks post implantation using the new ortho-implant type II anchor system
device (Orthosystem Straumann, Basel, Switzerland).
124 participants, mainly adult males or females, whose diagnoses require
temporary stationary implant-based anchorage treatment will be randomized 1:1 to
one of two treatment groups: group 1 will receive a loading of implant standard
therapy after a healing period of 12 week (gold standard), whereas group 2 will
receive an early loading of orthodontic implants within 1 week after implant
insertion. Participants will be at least followed for 12 months after implant
placement.
The primary endpoint is to investigate the behavior of early loaded palatal
implants in order to find out if shorter healing periods might be justified to
accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on
achievement of orthodontic treatment goals and quantity of direct implant-bone
interface of removed bone specimens. As tertiary objective, a histologic and
microtomography evaluation of all retrieved implants will be performed to obtain
data on the performance of the SLA surface in human bone evaluation of all
retrieved implants. Additionally, resonance frequency analysis (RFA, OsstellTM
mentor) will be used at different times for clinically monitoring the implant
stability and for histological comparison in order to measure the reliability of
the resonance frequency measuring device.
Trial registration:
Current Controlled Trials ISRCTN97142521.
