Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Study Overview

• Status: Unknown
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Device: twin block appliance; Device: modified twin block appliance

Detailed Description

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Skeletal Class II relationship (ANB > 4°).
2. Mandibular retrognathy (SNB < 78°).
3. Overjet ≥ 5 mm.
4. Minimal crowding in dental arches (≤4 mm).
5. Class II molar relation.
6. Growing female patients.
7. Patients with CMV3 maturation stage of the cervical verbrae.

Exclusion Criteria:

1. No history of orthodontic treatment either prior to or during functional Appliance therapy.
2. Posterior cross bites or severe maxillary transverse deficiency.
3. Severe facial asymmetry determined by clinical or radiographical examination.
4. Poor oral hygiene.
5. Systemic diseases that may affect the orthodontic treatment results.
6. Patients past their peak growth spurt.

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: twin block appliance; this group will receive conventional twin block appliance and followed up every month for 9 months.	Device: twin block appliance; a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic); Other Names: mandibular functional appliance
Experimental: modified twin block appliance group; modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months	Device: modified twin block appliance; a convetional twin block functional appliance that enhances mandibular growth in growing patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
enhancing mandibular skeletal growth	it will be assessed by measuring the incremental growth by quick ceph (mm)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dentoalveolar changes	quick ceph (mm)	9 months
Improvement of soft tissue profile	quick ceph (mm)	9 months
Patient's compliance	table chart (no of hours/day)	9 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

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-2018-08-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

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