Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06467240 |
| Other study ID # |
984/3700 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
July 20, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Al-Azhar University |
| Contact |
Rafaat Rafaat el ghetany |
| Phone |
380-238-9674 |
| Email |
mohamedellamey11[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted
with Micro-osteo perforation (MOPs) in adults
Description:
Transverse maxillary deficiencies are common orthodontic issues observed by professionals. It
is estimated that 9.4% of adult orthodontic patients have a transverse maxillary deficiency
in combination with a posterior cross bite. A normal transverse skeletal relationship between
basal bones is fundamental to achieving a satisfactory and stable occlusion.
Therefore, to correct a maxillary transverse deficiency, palatal expanders are needed. Since
Haas popularized this technique in the early 1960s, rapid palatal expanders are the most
popular devices of choice, characterized by safety, predictability and efficiency.
The rapid process of activation reduces dental movements (side effects) thus enabling
skeletal expansion. Surprisingly, only 30% of the expander opening seems to result in suture
opening, whereas one-third reflects alveolar bending and another 30% dental movement.
During activations of traditional tooth-borne rapid palatal expansion devices, heavy
transverse forces are generated in a short period of time, causing disruption of the inter
sutural tissue thus producing midpalatal suture opening.
On many occasions, these expansion forces in-vivo are in the range of 75-120 N, measured at
the level of the hyrax screw of the connecting stainless-steel wire arms at the buccal
crowns. In vitro skeletal hybrid expanders, before plastic deformation, demonstrated
expansion force values from 67 ± 13 N to 183 ± 48 N when tested on the mini-implant's
reinforced bone-anchored wire arms .With these forces, the opening of the palatal suture in
adolescents or young adults can be frequently unsuccessful.
Therefore, conventional expanders, under high loads, deform prematurely or create excessive
molar tipping or mucosa soreness before
reaching midpalatal suture opening. If these expansion forces are not able to open the
suture, surgically assisted rapid palatal expansion (SARPE) is suggested.
In addition, scientific papers do not provide information of the amount of force at the level
of the midpalatal suture and the limit of plastic deformation. Solely anchored on orthodontic
mini-implants (OMIs) and placed in the anterior-middle palate. These bone anchored expanders
seem to improve the aforementioned drawbacks and provide greater expansion forces to
facilitate midpalatal suture opening even in adult patients so as to avoid SARPE.
Major areas of resistance to hybrid rapid maxillary expansion are mid palatine suture and the
pterygomaxillary articulation. With increasing the age, the interdigitation at sutures
increases making the site more rigid. The concept of regional acceleratory phenomenon (RAP)
can be used for such clinical challenges by using mild surgical trauma induced by Micro-osteo
perforation (MOPs) to produce localized inflammation with the mid palatine suture being the
only sight easily accessible for intervention, minimally invasive procedures like Micro-osteo
perforation (MOPs) can be used to disrupt the mid palatine suture to make it more pliable to
expansion forces.
Micro-osteo perforation (MOPs) along the mid palatal suture which will induce rapid
acceleratory phenomenon which would accelerate the bone turnover and reduce the regional bone
density leading to transient osteopenia and thus bringing out changes in the transverse
dimension.
Cone beam computed tomography (CBCT) allows better imaging at low radiation dosages and
presents a clear view of bony structures, tooth position, and type of palatal suture fusion
with minimal image distortion. Although hybrid rapid maxillary expansion and minimally
invasive surgical techniques are often used in orthodontic clinical practice, only a few
studies have been published in the literature on large groups of patients that present
possible complications that may occur after practicing this method of orthodontic treatment.
