NCT05599074

Brief Summary

This study investigated treatment effects and stability of anterior open bite cases using extrusion arches

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

October 18, 2022

Last Update Submit

November 5, 2022

Conditions

Anterior Open Bite Malocclusion

Keywords

extrusion archesanterior open bitestabilityextrusionintrusion

Outcome Measures

Primary Outcomes (15)

  • SNA angle

    The anteroposterior position of maxillary base to the anterior cranial base.

    18 months

  • SNB angle

    The anteroposterior position of mandibular base to the anterior cranial base.

    18 months

  • ANB angle

    The anteroposterior position of maxillary base to the mandibular base.

    18 months

  • SN-MP angle

    Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).

    18 months

  • PP-MP angle

    The angle between palatal plane (ANS-PNS) and mandibular plane.

    18 months

  • AFH

    Anterior facial height, the measurement between Nasion (N) and Menton (Me).

    18 months

  • interincisal angle

    \- The inner angle between the long axis of the maxillary central incisor and long axis of mandibular central incisor.

    18 months

  • L1 to MP in mm

    \- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.

    18 months

  • L1 to MP angle

    The angle between long axis of the most anterior central incisor and the mandibular plane.

    18 months

  • overbite

    Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.

    18 months

  • U1 to PP angular and linear measurements

    -The angle and perpendicular distance between long axis of the most anterior upper central incisor and the Palatal plane (ANS-PNS).

    18 months

  • u6 to pp angle

    -The angle between the axis between mesial cusp tip and mesiobuccal root apex of the upper first molar and the palatal plane.

    18 months

  • U6 to PP in mm

    -The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.

    18 months

  • L6 to MP angle

    The angle between the axis between mesial cusp tip and mesial root apex of the lower first molar and the mandibular plane.

    18 months

  • L6 to MP in mm

    The perpendicular distance between mesial cusp tip of the lower first molar and the mandibular plane.

    18 months

Study Arms (1)

AOB adults

EXPERIMENTAL

adult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion

Device: extrusion arch

Interventions

extrusion archDEVICE

A stainless steel pre-formed arch wire custom made by placing V-bends 3-5 mm mesial to the molar tubes, placed into the auxiliary molar tubes after leveling phase and tied over the main arch wire distal to the lateral incisors

AOB adults

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion

You may not qualify if:

  • increased incisal show at rest
  • gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria faculty of Dentistry

Alexandria, 21589, Egypt

Location

Study Officials

  • tasneem hammad, BDS

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • hanan ismail, PHD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Before and after design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 31, 2022

Study Start

April 1, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

EG(1)