Effects of Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners

NCT ID: NCT07169968

Last Updated: 2025-09-12

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-11-15

Brief Summary

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this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations

Detailed Description

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This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations

Conditions

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Mandibular Dental Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group 1: Clear aligner treatment

the control group that will receive clear aligner treatment for lower anterior treatment without micro-osteoperforations

Group Type ACTIVE_COMPARATOR

clear aligners group

Intervention Type DEVICE

patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished

group 2: clear aligner treatment with micro-osteoperforations

the experimental group that will receive clear aligner treatment for lower anterior treatment with micro-osteoperforations using mini-implants for acceleration of tooth movement and improving aligner's tracking

Group Type EXPERIMENTAL

micro-osteoperforations group

Intervention Type DEVICE

patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment.

Interventions

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clear aligners group

patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished

Intervention Type DEVICE

micro-osteoperforations group

patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment.

Intervention Type DEVICE

Other Intervention Names

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control group group 1 experimental group group 2

Eligibility Criteria

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Inclusion Criteria

1. Adult patients with age ranging from 18 to 35 years.
2. Healthy periodontium.
3. Presence of full set of permanent dentition excluding third molars.
4. Patients requiring non-extraction orthodontic treatment in the mandibular arch.
5. Mandibular anterior little's irregularity index from 3 to 6.
6. No spaces in the mandibular arch.

Exclusion Criteria

1. Presence of retained primary teeth in the mandibular arch.
2. Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs)
3. Vulnerable patients.
4. Smokers.
5. Pregnant female patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 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

Locations

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Department of orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abassia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDASU-Rec ID052429

Identifier Type: -

Identifier Source: org_study_id

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