Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Primary Purpose
Posterior Crossbite
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tooth borne hyrax expander
microosteoperforation
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Crossbite
Eligibility Criteria
Inclusion Criteria:
- Female adolescent patients with an age range 11- 14 years.
- Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
- Normal vertical growth pattern.
- Fully erupted maxillary first premolars and first permanent molars.
Exclusion Criteria:
- Previous orthodontic treatment.
- Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
- Active periodontal affection or severe gingival inflammation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tooth borne hyrax expander group
tooth borne hyrax expander with microosteoperforation
Arm Description
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
Outcomes
Primary Outcome Measures
Dental tipping.
it will be measured in degree on Cone beam computed tomography image using a software
Alveolar bending
it will be measured in degree on Cone beam computed tomography image using a software
Dental changes(transverse).
it will be measured in mm on Cone beam computed tomography image using a software
Skeletal changes(transverse, anteroposterior and vertical)
it will be measured in mm on Cone beam computed tomography image using a software
Secondary Outcome Measures
Pattern of expansion
it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03772379
Brief Title
Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Official Title
Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.
Detailed Description
The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Crossbite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tooth borne hyrax expander group
Arm Type
Experimental
Arm Description
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .
Arm Title
tooth borne hyrax expander with microosteoperforation
Arm Type
Experimental
Arm Description
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
Intervention Type
Device
Intervention Name(s)
tooth borne hyrax expander
Intervention Description
ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.
Intervention Type
Procedure
Intervention Name(s)
microosteoperforation
Intervention Description
ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed.
Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece .
Primary Outcome Measure Information:
Title
Dental tipping.
Description
it will be measured in degree on Cone beam computed tomography image using a software
Time Frame
an average1 year
Title
Alveolar bending
Description
it will be measured in degree on Cone beam computed tomography image using a software
Time Frame
an average1 year
Title
Dental changes(transverse).
Description
it will be measured in mm on Cone beam computed tomography image using a software
Time Frame
an average1 year
Title
Skeletal changes(transverse, anteroposterior and vertical)
Description
it will be measured in mm on Cone beam computed tomography image using a software
Time Frame
an average1 year
Secondary Outcome Measure Information:
Title
Pattern of expansion
Description
it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.
Time Frame
an average1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female adolescent patients with an age range 11- 14 years.
Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
Normal vertical growth pattern.
Fully erupted maxillary first premolars and first permanent molars.
Exclusion Criteria:
Previous orthodontic treatment.
Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
Active periodontal affection or severe gingival inflammation.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
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