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

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

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.

Study Overview

• Status: Unknown
• Conditions: Skeletal Class 2
• Intervention / Treatment: Device: flat fixed anterior bite plane; Device: modified inclined fixed anterior bite plane

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry,Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mandibular position	assessed onCBCT	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary anteroposterior and vertical growth change.	assessed onCBCT	8 months
Anteroposterior and vertical dental changes.	assessed onCBCT	8 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 7, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malocclusion; Micrognathism
• Other Study ID Numbers: CEBD-CU-2017-10-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No