CClinicalTrials.gg
Status unknownNCT03308175Updated Feb 6, 2018

Evaluation of the Effects of Flat and Modified Inclined Fixed Anterior Bite Planes on Mandibular Position in Growing Females With Skeletal Class 2 Malocclusion Due to Mandibular Deficiency and Deep Bite

An interventional study of flat fixed anterior bite plane and modified inclined fixed anterior bite plane in Skeletal Class 2, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
10 Years to 13 Years
Sex
Female
01

Study summary

This study will be conducted to see if unlocking mandible from deep bite in growing females by flat fixed anterior bite plane will change mandibular position in skeletal mandibular deficiency and if there is a difference in the change of mandibular position if we assisted the mandible by holding it in a more forward position by modified inclined fixed anterior bite plane .These results will be compared to normal mandibular growth from previous records of a matched control group in the discussion afterthat.

Read the detailed description

Two groups of patients the first for flat fixed anterior bite plane, the second for modified inclined fixed anterior bite plane.Full records are taken to patients. Then bands selection for upper first molars,impressions for upper arch with bands fitted and impression to lower arch, fabrication of either flat/ modified inclined fixed anterior bite planes and cementation in patient's mouth,evaluation of results after 8 months.

02

Conditions studied

  • Skeletal Class 2
03

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • (1)Growing females aged 10-13 (2)Skeletal maturational stage: stages 3,4 of the cervical maturational index CVMI.

    (3) low-angle/moderate normal growth pattern (4) Overjet of 4-7 mm as measured from labial surface of upper incisors to labial surface of lower incisors (5)Skeletal class 2 due to mandibular deficiency 77 degrees \<SNB> 73 degrees (6) Normal or slightly protruded maxillary base (7) All cases had dental deep bite; with the upper incisors covering more than 50% of the height of the lower incisors.

    (8)Only deep bite cases that required extrusion of posterior teeth.

Exclusion Criteria:1- No syndromic or medically compromised patients 2- No growth disorders 3- No use of other appliances before or during the period of functional treatment

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    flat fixed anterior bite plane

    Bands selection will be done for upper 6s. Alginate impressions taken and molar bands are fitted in place into the impressions. Impressions for upper and lower arches are poured with stone plaster. Mounting on simple hinge articulator will be done. Lingual arches (diameter 1 mm) with anterior acrylic bite plates with thickness enough to separate posterior teeth 4mm . The acrylic bite planes were in occlusion with the lower anterior teeth and extended sagittally 2-3mm beyond edges of lower incisors. Finishing ,polishing and cementation into patient's mouth with glass ionomer cement.

    Device: flat fixed anterior bite plane

  • Experimental
    modified inclined fixed anterior bite plane

    In modified inclined fixed anterior bite plane,the modification is that some indentations will be done in the acrylic part where the lower anteriors will fit such that mandible will be held in a more forward position. These indentations will be relieved lingually to overcome it's flaring effect on mandibular incisors .The inclined plane will be 60 degrees to occlusal plane. Functional bite will be taken to position the mandible in the proper position forward. Bite taken edge-to-edge for appliance construction. Mounting upper and lower casts on simple hinge articulator for construction of modified flat fixed anterior bite plane

    Device: modified inclined fixed anterior bite plane

Interventions

  • Deviceflat fixed anterior bite plane

    It causes unlocking mandible from deep bite in growing females

  • Devicemodified inclined fixed anterior bite plane

    It causes unlocking mandible from deep bite in growing females plus putting the mandible in a more forward position

05

What researchers measure

Primary outcomes

  1. Change in mandibular position

    assessed onCBCT

    Time frame: 8 months

Secondary outcomes

  1. Maxillary anteroposterior and vertical growth change.

    assessed onCBCT

    Time frame: 8 months

  2. Anteroposterior and vertical dental changes.

    assessed onCBCT

    Time frame: 8 months

06

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry,Cairo University
    Cairo, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT03308175
Lead sponsor
Cairo University
Responsible party
Yomna Elfiky (Resident, Cairo University) — Principal investigator
First posted
Oct 12, 2017
Start date
Nov 30, 2017
Primary completion
Sep 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Feb 6, 2018

Study contacts

yomna Elfiky, resident
Contact
princessyomna7@outlook.com
01001987078

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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