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

Skeletal Class 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308175
• Other study ID #: CEBD-CU-2017-10-04
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2017
• Last updated: February 2, 2018
• Start date: November 30, 2017
• Est. completion date: September 2018

Study information

• Verified date: October 2017
• Source: Cairo University
• Contact: yomna Elfiky, resident
• Phone: 01001987078
• Email: princessyomna7[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Skeletal Class 2

Intervention

Device:
• flat fixed anterior bite plane
It causes unlocking mandible from deep bite in growing females
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry,Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mandibular position	assessed onCBCT	8 months
Secondary	Maxillary anteroposterior and vertical growth change.	assessed onCBCT	8 months
Secondary	Anteroposterior and vertical dental changes.	assessed onCBCT	8 months