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

NCT03772379 | Unknown DMC

• 1 other identifier: PhD Protocol
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posterior Crossbite

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Pattern of expansion

  an average1 year

Study Arms (2)

tooth borne hyrax expander group

EXPERIMENTAL

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

tooth borne hyrax expander with microosteoperforation

EXPERIMENTAL

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

Procedure: microosteoperforation

Interventions

tooth borne hyrax expander DEVICE

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.

tooth borne hyrax expander group

microosteoperforation PROCEDURE

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 .

tooth borne hyrax expander with microosteoperforation

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher assisstant at the national research center

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 11, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 11, 2018

Record last verified: 2018-12