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

Posterior Crossbite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03772379
• Other study ID #: PhD Protocol
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: May 2020

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: May 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Malocclusion
• Posterior Crossbite

Intervention

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.

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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental tipping.	it will be measured in degree on Cone beam computed tomography image using a software	an average1 year
Primary	Alveolar bending	it will be measured in degree on Cone beam computed tomography image using a software	an average1 year
Primary	Dental changes(transverse).	it will be measured in mm on Cone beam computed tomography image using a software	an average1 year
Primary	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	Pattern of expansion	it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.	an average1 year