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NCT05171738 Clinical Trial

Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations

Class II Division 1 Malocclusion Clinical Trial

Official title:
Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05171738
Other study ID # 788/309
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date November 1, 2023

Study information
Verified date April 2022
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.

Description:

Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - Inclusion criteria: All patients should satisfy the following criteria:- 1. Age range from 13-17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normodivergent skeletal pattern 5. No posterior crowding or diastemas. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral and general health. 9. No systemic disease/medication that could interfere with OTM. 10. No previous orthodontic treatment. Exclusion Criteria: - Exclusion criteria: 1. Patient diagnosed to have an indication for non-extraction approach. 2. Poor oral hygiene or periodontally compromised patient. 3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions. 4. Previous orthodontic treatment

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• skeletally anchored distal jet
used from day one and activated every month

Locations
Country Name City State
Egypt Al azhar university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in molar postion using cephalometric x_ray for measurment from start of treatment until study completion, an average of 1 year
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Completed NCT03467555 - Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates Using Cone Beam Computed Tomography N/A