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Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

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ClinicalTrials.gov Identifier: NCT03772379
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mennatallah Ihab Elsayed, Cairo University

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.

Condition or disease Intervention/treatment Phase
Posterior Crossbite Device: tooth borne hyrax expander Procedure: microosteoperforation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: tooth borne hyrax expander group
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .
Device: tooth borne hyrax expander
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.

Experimental: tooth borne hyrax expander with microosteoperforation
patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
Procedure: microosteoperforation

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 Measures :
  1. Dental tipping. [ Time Frame: an average1 year ]
    it will be measured in degree on Cone beam computed tomography image using a software

  2. Alveolar bending [ Time Frame: an average1 year ]
    it will be measured in degree on Cone beam computed tomography image using a software

  3. Dental changes(transverse). [ Time Frame: an average1 year ]
    it will be measured in mm on Cone beam computed tomography image using a software

  4. Skeletal changes(transverse, anteroposterior and vertical) [ Time Frame: an average1 year ]
    it will be measured in mm on Cone beam computed tomography image using a software


Secondary Outcome Measures :
  1. Pattern of expansion [ Time Frame: an average1 year ]
    it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Mennatallah Ihab Elsayed, researcher assisstant at the national research center, Cairo University
ClinicalTrials.gov Identifier: NCT03772379    
Other Study ID Numbers: PhD Protocol
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases