Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage

July 11, 2024 updated by: Zeyad Mahmoud, Mansoura University

Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.

Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.

Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of study:

this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.

Participant and eligibility criteria:

The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.

Intervention:

written and informed consents will be taken from the patients.

Group 1:

  • Two metal bands will be chosen and fitted on the maxillary first molars.
  • Rubber base impression material will be taken with bands in place.
  • Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
  • Send it to the LAB for appliance fabrication.
  • At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
  • The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.

Group 2:

  • Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
  • Rubber base impression material will be taken with bands in place.
  • Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
  • Send it to the LAB for appliance fabrication.
  • At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Dental class II.
  • No or mild to moderate maxillary teeth crowding.
  • Erupted or partially erupted maxillary second molars.
  • No previous orthodontic therapy.
  • Absence or minimum crowding in the mandibular arch.
  • Good oral hygiene.

Exclusion Criteria:

  • Dental class I, III
  • severe maxillary teeth crowding.
  • Extracted or badly decayed maxillary first molars.
  • Previous orthodontic therapy.
  • Severe crowding in the mandibular arch.
  • Bad oral hygiene.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct bone anchored pull distal slider
The appliance will be cemented on the maxillary first molars and two miniscrews will be placed in their positions. The appliance will be activated by closed coil spring, which apply 300g force.
Device: Direct bone anchored pull distal slider
distalization from the palatal side only.
Experimental: Indirect bone anchored dual force distalizer.
The appliance will be cemented on the teeth and two miniscrews will be placed in their positions. Activated by compressing the NiTi open coil spring from the buccal and palatal sides.
Device: Indirect bone anchored dual force distalizer.
distalization from the palatal and buccal sides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anteroposterior skeletal measurements
Time Frame: 8 months
From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
8 months
Vertical skeletal measurements
Time Frame: 8 months
From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
8 months
Dental angular measurements
Time Frame: 8 months
From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping.
8 months
Amount of distalization
Time Frame: 8 months
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm.
8 months
Amount of intrusion
Time Frame: 8months

From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm.

.
8months
Amount of expansion
Time Frame: 8 months
From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm.
8 months
Amount of rotation
Time Frame: 8 months
From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation.
8 months

Collaborators and Investigators

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

Sponsor

Mansoura 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)

June 8, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Doctor Zeyad Mahmoud Ali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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