Teeth Decrowding With and Without Fixed Appliances

May 10, 2024 updated by: Samer Mheissen

The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Samer Mheissen, orthodontics
  • Phone Number: 00962795710426
  • Email: mheissen@yahoo.com

Study Contact Backup

Study Locations

  • Jordan
      • Amman, Jordan, 00962
        • Recruiting
        • Medical Services
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Fixed appliances
MBT Brackets 0.022 inch
No Intervention: Without braces
Extraction of premolars and only observing the case over time. The measurements would be done using models each month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior teeth alignment every 4 weeks at each time point.
Time Frame: 6 months
The cumulative before extraction and space closure for 4 months (mean difference before and after)..
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molar anchorage loss at each time point.
Time Frame: 6 months
The anchorage loss of molars will be measured over time using the models.
6 months
Gingival invagination
Time Frame: 9 months
this will be measured by visual inspection intraorally.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samer Mheissen

Investigators

  • Principal Investigator: Samer Mheissen, DDS, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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