Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

• Sponsor: Al-Azhar University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05193513
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

Condition or Disease	Intervention/Treatment	Phase
Cross Bite	Device: hybrid expanders	N/A

Detailed Description

the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Tow Maxillary Hybrid Expanders -Perpendicular Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study
• Actual Study Start Date: Jul 10, 2021
• Anticipated Primary Completion Date: Jun 10, 2023
• Anticipated Study Completion Date: Oct 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group (1) tow perpendicular miniscrews supported hybrid expanders	Device: hybrid expanders; tow maxillary hybrid expanders supported anteriorly with tow miniscrews
Experimental: group (2) tow angulated miniscrews supported hybrid expanders	Device: hybrid expanders; tow maxillary hybrid expanders supported anteriorly with tow miniscrews

Outcome Measures

Primary Outcome Measures

1. change in maxillary width [12 weeks following end of treatment]

   millimeter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Medically free male or female patients

2. Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.

3. The patient should have no missing teeth except third molars.

4. Age ranged from 12 to 18 years old.

5. The patient should have a good gingival condition.

6. The patient should have a good periodontal condition.

Exclusion Criteria:

1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al azhar university	Cairo		Egypt	11311

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdallah EL sayed Mohamed Hassan, Comparison of tow maxillary hybrid expanders -perpendicular screw Supported versus lateral angulated one; a prospective randomized clinical study, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05193513
• Other Study ID Numbers: 628/3133
• First Posted: Jan 18, 2022
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malocclusion

Study Results

No Results Posted as of Jan 18, 2022