Teeth Decrowding With and Without Fixed Appliances

Tooth Crowding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416189
• Other study ID #: Ortho-0001
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Samer Mheissen
• Contact: Samer Mheissen, orthodontics
• Phone: 00962795710426
• Email: mheissen[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Tooth Crowding

Intervention

Device:
• Fixed appliances
MBT Brackets 0.022 inch

Locations

Country	Name	City	State
Jordan	Medical Services	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Samer Mheissen

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior teeth alignment every 4 weeks at each time point.	The cumulative before extraction and space closure for 4 months (mean difference before and after)..	6 months
Secondary	Molar anchorage loss at each time point.	The anchorage loss of molars will be measured over time using the models.	6 months
Secondary	Gingival invagination	this will be measured by visual inspection intraorally.	9 months