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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

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ClinicalTrials.gov Identifier: NCT03308175
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yomna Elfiky, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Skeletal Class 2 Device: flat fixed anterior bite plane Device: modified inclined fixed anterior bite plane Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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: A Randomized Controlled Trial
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
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
It causes unlocking mandible from deep bite in growing females

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




Primary Outcome Measures :
  1. Change in mandibular position [ Time Frame: 8 months ]
    assessed onCBCT


Secondary Outcome Measures :
  1. Maxillary anteroposterior and vertical growth change. [ Time Frame: 8 months ]
    assessed onCBCT

  2. Anteroposterior and vertical dental changes. [ Time Frame: 8 months ]
    assessed onCBCT



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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


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): NCT03308175


Contacts
Contact: yomna Elfiky, resident 01001987078 princessyomna7@outlook.com

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

Responsible Party: Yomna Elfiky, Resident, Cairo University
ClinicalTrials.gov Identifier: NCT03308175     History of Changes
Other Study ID Numbers: CEBD-CU-2017-10-04
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases