Teeth Decrowding With and Without Fixed Appliances

NCT06416189 | Recruiting DMC

• 1 other identifier: Ortho-0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Crowding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Molar anchorage loss at each time point.

  6 months

• Gingival invagination

  9 months

Study Arms (2)

Braces

ACTIVE COMPARATOR

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

Without braces

NO INTERVENTION

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

Interventions

Fixed appliances DEVICE

MBT Brackets 0.022 inch

Braces

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• Cases requiring orthognathic surgery.
• History of systemic and medical illness.
• Contraindication of extraction.
• Previous history of orthodontic treatment.
• Poor oral hygiene.
• Nickel allergy.

Sponsors & Collaborators

• Samer Mheissen: lead

Study Sites (1)

Medical Services

Amman, 00962, Jordan

RECRUITING

MeSH Terms

Conditions

Malocclusion

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Samer Mheissen, DDS

  Private Practice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samer Mheissen, orthodontics

CONTACT

00962795710426; mheissen@yahoo.com

Haris Khan, PhD

CONTACT

drhariskhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The two groups will have lingual arches. However, patients without braces will not be informed about their braces before 5 months of trial initiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Two groups; one with fixed braces and one without fixed braces.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: May 16, 2024
• Study Start: February 2, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months

Locations

JO (1)