NCT02901678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

September 10, 2016

Last Update Submit

August 1, 2018

Conditions

Keywords

skelatal open bite, posterior intrusion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Average rate of intrusion

    6 months

  • Root resorption

    6 months

  • Tipping

    6 months

Study Arms (2)

Intrusion by 200 g

ACTIVE COMPARATOR

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

Device: Intrusion by 400 g

Intrusion by 400 g

EXPERIMENTAL

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

Device: Intrusion by 400 g

Interventions

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

Intrusion by 200 gIntrusion by 400 g

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal resident

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 15, 2016

Study Start

November 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Participants data will not be exposed except for research committee

Locations