Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite

• Sponsor: Mansoura University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06015386
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite

Condition or Disease	Intervention/Treatment	Phase
Anterior Crossbite	Other: inclined plane; Other: clear aligner	N/A

Detailed Description

the study *include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
• Actual Study Start Date: Jun 22, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: inclined plane group treated with inclined plane	Other: inclined plane; 2 parallel groups one treated with clear aligner and other treated using inclined plane
Experimental: clear aligner group treated with clear aligner	Other: clear aligner; 2 parallel groups one treated with clear aligner and other treated using inclined plane

Outcome Measures

Primary Outcome Measures

1. (OHRQoL (Oral Health-related Quality of Life) [4 month]

   CPQ8-10 scores at two different points in time.

Secondary Outcome Measures

1. cephalometric analysis of data [4 month]

   compare cephalometric variables between two groups

2. 3D model measurements [4 month]

   compare 3D model measurements variable between 2 group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal range i.e. (The crossbite will be diagnosed as functional or dental)

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Exclusion Criteria:

1. Systemic conditions that may interfere with the treatment.

2. Bad habits that might jeopardize the appliance.

3. Transverse discrepancy.

4. Previous orthodontic treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	El Mansura		Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asmaa Salah, teaching assistant, Mansoura University
• ClinicalTrials.gov Identifier: NCT06015386
• Other Study ID Numbers: ACB
• First Posted: Aug 29, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Asmaa Salah, teaching assistant, Mansoura University: clear aligner , anterior crossbite , inclined plane
• Additional relevant MeSH terms: Malocclusion

Study Results

No Results Posted as of Aug 29, 2023