Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

March 6, 2024 updated by: Nouran Mohamed Abdelwahab Eissa, Tanta University

The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars

The patients will be selected according to the following criteria:

  1. Patient with full permanent dentition.
  2. Good oral hygiene.
  3. None of the patients had received any orthodontic treatment.
  4. Class II molar relationship.
  5. Minimal or no crowding in the mandibular arch.
  6. Non-extraction treatment plan with molar distalization.
  7. Low angle cases.
  8. No medical problems or active periodontal disease.

Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be divided into two groups:

Group 1: Consisted of 10 patients, their upper molar will be distalized with bone suppored Fast Back (Fast Back Rapid Distalizer, leone, s.p.a, Italy).

Group 2: Consisted of 10 patients, their upper molar will be distalized with bone supported modified Leaf Spring Self-Activated Expander. (Leaf Self Expander, leone, s.p.a, Italy).

  • Assessment of the 3D dentoskeletal treatment effects of the palatally bone supported Fast Back and palatally bone supported modified Leaf Spring Self-Activated Expander will be performed by using the CBCT scans.
  • Pretreatment CBCT (T1) and post-distalization until study completion with an average of 1 year (T2) for each subject

All data will be collected, tabulated and statistically analyzed using the SPSS.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 6620010
        • Faculty of Dentistry

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:

  • Patient with full permanent dentition.
  • Good oral hygiene.
  • Class II molar relationship.
  • Non-extraction treatment plan with molar distalization.
  • Low angle cases.
  • medical problems or active periodontal disease.

Exclusion Criteria:

  • The patients had received any orthodontic treatment.
  • Crowding in the mandibular arch.
  • Medical problems or active periodontal disease.

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
Experimental: Fast Back Rapid Distalizer
Group 1: Consisted of 10 patients, their upper molar will be distalized with bone suppored Fast Back (Fast Back Rapid Distalizer, leone, s.p.a, Italy).
Device: Insertion of the device intraorally
  • The distalizer appliance will be checked for adaptation intraorally, the two bands of the maxillary first molars will be fitted in their accurate position on the teeth.
  • The screw insertion will be carried out with the patient under local anesthesia.
  • They will be placed inside the two eyelets of the anterior arms of the screw in the appliance
Experimental: Modified Leaf Spring Self-Activated Expander
Group 2: Consisted of 10 patients, their upper molar will be distalized with bone supported modified Leaf Spring Self-Activated Expander. (Leaf Self Expander, leone, s.p.a, Italy).
Device: Insertion of the device intraorally
  • The distalizer appliance will be checked for adaptation intraorally, the two bands of the maxillary first molars will be fitted in their accurate position on the teeth.
  • The screw insertion will be carried out with the patient under local anesthesia.
  • They will be placed inside the two eyelets of the anterior arms of the screw in the appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D Dental and skeletal Cephalometric Measurements
Time Frame: Through study completion, an average of 1 year"
Using CBCT 3D Analysis
Through study completion, an average of 1 year"
2D Dental and skeletal Cephalometric Measurements
Time Frame: Through study completion, an average of 1 year"
Using CBCT 2D Analysis
Through study completion, an average of 1 year"

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: Safaa M Gaballah, Professor, Tanta University
  • Study Director: Shaimaa M Elmarhoumy, professor, Tanta University

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)

January 10, 2024

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

January 10, 2026

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTH 11-23 2097

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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