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The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

Primary Purpose

Orthodontics

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Intrusion by 400 g

About this trial

This is an interventional treatment trial for Orthodontics focused on measuring skelatal open bite, posterior intrusion

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult patients with an age range from 17 to 25.
Skeletal open bite.
Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm).
Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment.
Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion).
Full set of maxillary posterior dentition (first and second premolars, first molars at least).
No previous orthodontic treatment.

Exclusion Criteria:

Medically compromised patients.
Patients suffering from any congenital or hereditary diseases.
Smoking or any systemic diseases.
Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intrusion by 200 g

Intrusion by 400 g

Arm Description

Applying 200 g intrusive force for the maxillary posterior segment intrusion using miniscrews

Applying 400 g of Intrusive force for the maxillary posterior segment intrusion using miniscrews

Outcomes

Primary Outcome Measures

Amount of intrusion

The amount the upper posterior teeth have been intruded.

Rate of bite closure

The rate by which the open bite closes as a result of posterior segment intrusion

Secondary Outcome Measures

Average rate of intrusion

The amount of intrusion divided by the duration of intrusion

Root resorption

The amount of root resorption as a result of the intrusive force

Tipping

The amount of mesiodistal and buccolingual tipping of posterior teeth

Full Information

NCT ID

NCT02901678

First Posted

September 10, 2016

Last Updated

August 1, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02901678

Brief Title

The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

Official Title

The Effect of Two Different Force Magnitudes on Maxillary Posterior Segment Intrusion in Adult Patients With Skeletal Open Bite Using Temporary Anchorage Devices- A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion

Detailed Description

This randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthodontics

Keywords

skelatal open bite, posterior intrusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intrusion by 200 g

Arm Type

Active Comparator

Arm Description

Applying 200 g intrusive force for the maxillary posterior segment intrusion using miniscrews

Arm Title

Intrusion by 400 g

Arm Type

Experimental

Arm Description

Applying 400 g of Intrusive force for the maxillary posterior segment intrusion using miniscrews

Intervention Type

Device

Intervention Name(s)

Intrusion by 400 g

Intervention Description

using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.

Primary Outcome Measure Information:

Title

Amount of intrusion

Description

The amount the upper posterior teeth have been intruded.

Time Frame

6 months

Title

Rate of bite closure

Description

The rate by which the open bite closes as a result of posterior segment intrusion

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Average rate of intrusion

Description

The amount of intrusion divided by the duration of intrusion

Time Frame

6 months

Title

Root resorption

Description

The amount of root resorption as a result of the intrusive force

Time Frame

6 months

Title

Tipping

Description

The amount of mesiodistal and buccolingual tipping of posterior teeth

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients with an age range from 17 to 25. Skeletal open bite. Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm). Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment. Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion). Full set of maxillary posterior dentition (first and second premolars, first molars at least). No previous orthodontic treatment. Exclusion Criteria: Medically compromised patients. Patients suffering from any congenital or hereditary diseases. Smoking or any systemic diseases. Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.

Facility Information:

Facility Name

Faculty of Dentistry

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Participants data will not be exposed except for research committee

Learn more about this trial

The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

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