Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467240
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-19
Brief Title:
Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation MOPs in Adult
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation MOPs in Adults A Prospective Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation MOPs in adults
Detailed Description:
Transverse maxillary deficiencies are common orthodontic issues observed by professionals It is estimated that 94 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-implants 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
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-implants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None