The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial.

NCT ID: NCT06330571

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-27

Study Completion Date

2025-07-15

Brief Summary

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The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.

Detailed Description

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Conditions

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Orthodontic Aligners

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Molar distalization by aligners without attachment

Group Type ACTIVE_COMPARATOR

Molar distalization by aligners with attachment

Intervention Type DEVICE

1. Plaster dental models will be poured from the rubber base impression.
2. Digital dental models will be created through scanning of plaster dental models.
3. Planning of the aligners will be done on 3 shape clear aligner.
4. Aligners will be fabricated on 3d printed models.
5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
6. Patient will receive the following aligner after 2 weeks.
7. Follow up visits every 4weeks until 6 months.

Molar distalization by aligners with attachments

Group Type EXPERIMENTAL

Molar distalization by aligners with attachment

Intervention Type DEVICE

1. Plaster dental models will be poured from the rubber base impression.
2. Digital dental models will be created through scanning of plaster dental models.
3. Planning of the aligners will be done on 3 shape clear aligner.
4. Aligners will be fabricated on 3d printed models.
5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
6. Patient will receive the following aligner after 2 weeks.
7. Follow up visits every 4weeks until 6 months.

Interventions

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Molar distalization by aligners with attachment

1. Plaster dental models will be poured from the rubber base impression.
2. Digital dental models will be created through scanning of plaster dental models.
3. Planning of the aligners will be done on 3 shape clear aligner.
4. Aligners will be fabricated on 3d printed models.
5. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
6. Patient will receive the following aligner after 2 weeks.
7. Follow up visits every 4weeks until 6 months.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age more than15 years.
2. Gender; male or female.
3. Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
4. Mild crowding in the upper arch (≤ 4 mm).
5. Absence or previous extraction of the upper third molars.
6. Good compliance during the treatment

Exclusion Criteria

1. Transversal dental or skeletal discrepancies.
2. Extraction treatment (except for the third molar).
3. Periodontal disease. .
4. Prosthodontics rehabilitation of the maxillary molars.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noha E Sabet, Prof

Role: STUDY_CHAIR

Ain Shams University

Marwa s Abdelatef, Phd

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ainshams university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Ibrahim Atalla, PhD

Role: CONTACT

+201096290800

Noha E Sabet, Prof

Role: CONTACT

01001942079

Other Identifiers

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Aligners in distalization

Identifier Type: -

Identifier Source: org_study_id

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