Teeth Decrowding With and Without Fixed Appliances

NCT ID: NCT06416189

Last Updated: 2024-05-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-12-31

Brief Summary

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In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.

Detailed Description

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In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.

Conditions

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Tooth Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups; one with fixed braces and one without fixed braces.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The two groups will have lingual arches. However, patients without braces will not be informed about their braces before 5 months of trial initiation.

Study Groups

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Braces

Fixed appliance would be bonded post teeth extraction (premolars). subsequently, leveling and alignment using sequence of archwires would be followed. The measurements would be done using models each month.

Group Type ACTIVE_COMPARATOR

Fixed appliances

Intervention Type DEVICE

MBT Brackets 0.022 inch

Without braces

Extraction of premolars and only observing the case over time. The measurements would be done using models each month.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fixed appliances

MBT Brackets 0.022 inch

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Patients with permanent dentition between age group of 13 - 30 years.

* Maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
* Fully erupted teeth from 1st molar to the 1st molar.
* Patients with periodontally sound dentition.
* Patients with good general health. No previous history of extraction or orthodontic tooth movement.

Exclusion Criteria

* Cases requiring orthognathic surgery.

* History of systemic and medical illness.
* Contraindication of extraction.
* Previous history of orthodontic treatment.
* Poor oral hygiene.
* Nickel allergy.
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samer Mheissen

OTHER

Sponsor Role lead

Responsible Party

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Samer Mheissen

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samer Mheissen, DDS

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Medical Services

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Samer Mheissen, orthodontics

Role: CONTACT

00962795710426

Haris Khan, PhD

Role: CONTACT

Facility Contacts

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Hanan Habarneh, DDS

Role: primary

+962 7 7233 6009

Other Identifiers

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Ortho-0001

Identifier Type: -

Identifier Source: org_study_id

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