Evaluation of 3D Printed Modified Twin Block for Correction of Skeletal Class II Malocclusion in Growing Females

NCT04028661 | Unknown DMC

• 1 other identifier: 1993
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction. The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with untreated growing Class II control subjects.

Conditions

Class II Malocclusion, Division 1

Outcome Measures

Primary Outcomes (1)

• Skeletal Class II profile correction

  A-Effective mandibular length in mm B- SNB in degrees using lateral cephalogram

  8months

Secondary Outcomes (3)

• Inclination of anterior teeth

  8 months

• Soft tissue convexity correction

  8 months

• Patient acceptance

  8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

use of 3D printed Modified Twin Block Appliance.

Device: 3D printed Modified Twin Block Appliance

Untreated control group

NO INTERVENTION

No treatment phase of 8 months.

Interventions

3D printed Modified Twin Block Appliance DEVICE

It is a functional appliance for mandibular advancement designed digitally on virtual models.

Intervention group

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Females 10-13 years of age.
• Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
• Horizontal or neutral growth pattern. (MMP ≤ 30°)
• Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
• Cervical Vertebral Maturation (CVM) stage 3.

You may not qualify if:

• Systemic Disease.
• Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
• Extracted or missing upper permanent tooth/teeth (except for third molars).
• Facial Asymmetry.
• Para-functional habits.
• Severe proclination or crowding that requires extractions in the lower arch.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Donia Ezzeldin, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donia Ezzeldin, Master

CONTACT

01001200089; donia.ayman@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient and the of the pre and post treatment radiographs used for analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student

Model Details: The design of this randomized controlled trial is a parallel group, two arm, superiority trial with 1:1 allocation ratio.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 23, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share