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

• ClinicalTrials.gov Identifier: NCT03772379
• Recruitment Status: Unknown
• First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mennatallah Ihab Elsayed, Cairo University

Study Description

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.

Study Design

• 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

Arms and Interventions

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 .

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• Last Update Posted: December 11, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Malocclusion; Tooth Diseases; Stomatognathic Diseases