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

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.

Study Overview

• Status: Unknown
• Conditions: Posterior Crossbite
• Intervention / Treatment: Device: tooth borne hyrax expander; Procedure: microosteoperforation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental tipping.	it will be measured in degree on Cone beam computed tomography image using a software	an average1 year
Alveolar bending	it will be measured in degree on Cone beam computed tomography image using a software	an average1 year
Dental changes(transverse).	it will be measured in mm on Cone beam computed tomography image using a software	an average1 year
Skeletal changes(transverse, anteroposterior and vertical)	it will be measured in mm on Cone beam computed tomography image using a software	an average1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of expansion	it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.	an average1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: PhD Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No