The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion

Not Applicable

Recruiting

• Conditions: Jaw Protrusions
• Interventions: Device: Conventional facemask appliance; Device: Modified 3D printed facemask

• Registration Number: NCT06250127
• Lead Sponsor: University of Baghdad

Brief Summary

A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients

Detailed Description

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-31
• Status Verified: 2024-02
• Study First Posted: 2024-02-08
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-06-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet < 0 mm.
2. Concave profile with normal lower facial height (clinically and radiographically).
3. Good oral health free from caries and periodontal problems at the start of treatment.

Exclusion Criteria

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with vertical growth pattern or backward mandibular rotation tendency.
3. Patients with gross facial asymmetry.
4. Patients with cleft lip and palate and/or craniofacial syndrome
5. Patients with bad oral habit.
6. Active periodontal disease.
7. Previous history of TMJ signs or symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Conventional facemask)	Conventional facemask appliance	Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion.
Group 2 (Modified 3D printed facemask)	Modified 3D printed facemask	Modified facemask appliances will be used for growing patients who have Cl. III malocclusion.

Primary Outcome Measures

Name	Time	Method
Dentoskeletal and soft tissue changes	(T0) before starting the treatment and (T1) after 9 months of treatments.	Cephalometric analysis will be perfomed by measured different skeletal and soft tissue points in degrees at two time (T) intervals, (T0) before starting the treatment and (T1) at 9 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Skeletal and soft tissue changes	(T0) before starting the treatment and (T1) after 9 months of treatments.	Skeletal changes by comparing the changes of SNA, SNB and ANB angles in degrees using cephalometric x-rays at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.
Dental changes	(T0) before starting any treatment and (T1) after 9 months of treatments	Dental changes will be evalauted by comparing over jet changes in millimeters assessed using study models.at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.

Trial Locations

Locations (2)

Mushriq Abid; 🇮🇶 Baghdad, Iraq

College of Dentistry-University of Baghdad; 🇮🇶 Baghdad, Al-Rusafa, Iraq