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

NCT ID: NCT03772379

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-05-31

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.

Conditions

Posterior Crossbite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 .

Group Type: EXPERIMENTAL

tooth borne hyrax expander

Intervention Type: 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 with microosteoperforation

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

Group Type: EXPERIMENTAL

microosteoperforation

Intervention Type: 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 .

Interventions

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.

Intervention Type: DEVICE

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 .

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mennatallah Ihab Elsayed

researcher assisstant at the national research center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PhD Protocol

Identifier Type: -

Identifier Source: org_study_id