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The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

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ClinicalTrials.gov Identifier: NCT02901678
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Heba El-Sayed Kamel Akl, Cairo University

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

Condition or disease Intervention/treatment Phase
Orthodontics Device: Intrusion by 400 g Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

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.




Primary Outcome Measures :
  1. Amount of intrusion [ Time Frame: 6 months ]
    The amount the upper posterior teeth have been intruded.

  2. Rate of bite closure [ Time Frame: 6 months ]
    The rate by which the open bite closes as a result of posterior segment intrusion


Secondary Outcome Measures :
  1. Average rate of intrusion [ Time Frame: 6 months ]
    The amount of intrusion divided by the duration of intrusion

  2. Root resorption [ Time Frame: 6 months ]
    The amount of root resorption as a result of the intrusive force

  3. Tipping [ Time Frame: 6 months ]
    The amount of mesiodistal and buccolingual tipping of posterior teeth



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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901678


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt
Sponsors and Collaborators
Cairo University

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Responsible Party: Heba El-Sayed Kamel Akl, Internal resident, Cairo University
ClinicalTrials.gov Identifier: NCT02901678     History of Changes
Other Study ID Numbers: 121888
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants data will not be exposed except for research committee

Keywords provided by Heba El-Sayed Kamel Akl, Cairo University:
skelatal open bite, posterior intrusion