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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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

flat fixed anterior bite plane

modified inclined fixed anterior bite plane

About this trial

This is an interventional treatment trial for Skeletal Class 2

Eligibility Criteria

10 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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

-

Sites / Locations

Faculty of Dentistry,Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

flat fixed anterior bite plane

modified inclined fixed anterior bite plane

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in mandibular position

assessed onCBCT

Secondary Outcome Measures

Maxillary anteroposterior and vertical growth change.

assessed onCBCT

Anteroposterior and vertical dental changes.

assessed onCBCT

Full Information

NCT ID

NCT03308175

First Posted

October 7, 2017

Last Updated

February 2, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03308175

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skeletal Class 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

flat fixed anterior bite plane

Arm Type

Experimental

Arm Description

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.

Arm Title

modified inclined fixed anterior bite plane

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

flat fixed anterior bite plane

Intervention Description

It causes unlocking mandible from deep bite in growing females

Intervention Type

Device

Intervention Name(s)

modified inclined fixed anterior bite plane

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in mandibular position

Description

assessed onCBCT

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Maxillary anteroposterior and vertical growth change.

Description

assessed onCBCT

Time Frame

8 months

Title

Anteroposterior and vertical dental changes.

Description

assessed onCBCT

Time Frame

8 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yomna Elfiky, resident

Phone

01001987078

Email

princessyomna7@outlook.com

Facility Information:

Facility Name

Faculty of Dentistry,Cairo University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Skeletal Class 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial