The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

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

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

Study Overview

• Status: Completed
• Conditions: Orthodontics
• Intervention / Treatment: Device: Intrusion by 400 g

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrusion by 200 g; Applying 200 g intrusive force for the maxillary posterior segment intrusion using miniscrews	Device: Intrusion by 400 g; using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.
Experimental: Intrusion by 400 g; Applying 400 g of Intrusive force for the maxillary posterior segment intrusion using miniscrews	Device: Intrusion by 400 g; using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intrusion	The amount the upper posterior teeth have been intruded.	6 months
Rate of bite closure	The rate by which the open bite closes as a result of posterior segment intrusion	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average rate of intrusion	The amount of intrusion divided by the duration of intrusion	6 months
Root resorption	The amount of root resorption as a result of the intrusive force	6 months
Tipping	The amount of mesiodistal and buccolingual tipping of posterior teeth	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 10, 2016
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: skelatal open bite, posterior intrusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: 121888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants data will not be exposed except for research committee