CLINICAL TRIAL TO COMPARE AND EVALUATE THE EFFECTIVENESS OF LOW INTENSITY PULSED ULTRASOUND (LIPUS) AND LOW-LEVEL LASER THERAPY (LLLT) IN TREATING SKELETAL CLASS II CASES WITH FUNCTIONAL APPLIANCES.

Not yet recruiting

• Conditions: healthy patients

• Registration Number: CTRI/2021/12/038869
• Lead Sponsor: Sri Hasanamba dental College and Hospital

Brief Summary

Class II malocclusions are frequently encountered in orthodontic practices globally and in India. Class II molar relationships occur in a variety of skeletal and dental configurations. The most consistent diagnostic finding in Class II malocclusion is mandibular skeletal retrusion. For many adults with Class II malocclusion with mandibular deficiency, optimal overall results are best obtained with surgical orthodontic approach. However, treating skeletal Class II malocclusions in growing patients by using mandibular propulsive functional appliances, believed to produce satisfactory improvement in facial aesthetics and minimize the need for surgical intervention later. The effects of functional appliances on the remodeling of condyle-glenoid fossa complex have been widely documented in literature. Considering the positive effects of LIPUS and LLLT on condylar regeneration, these methods are used to shorten treatment period for skeletal Class II malocclusion. At present no studies are reported in the literature which compares the effects of LIPUS and LLLT in accelerating condylar regeneration, hence this proposed study will be taken up to compare and evaluate the effectiveness of Low Intensity Pulsed Ultrasound (LIPUS) and Low-Level Laser Therapy (LLLT) in treating skeletal Class II cases with functional appliances.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-21
• Study Start: 2021-12-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patient age group between 9-15 2.
• Skeletal Class II malocclusion with ANB ≥ 4 3.
• Pre-pubertal patients with CVMI stage below 4 4.
• Positive VTO 5.
• Orthognathic maxilla with retrognathic mandible 6.
• Overjet greater than 5mm 7.
• Average to horizontal growth pattern 8.
• Patients who are indicated for mandibular advancement using twin block functional appliance.

Exclusion Criteria

• Prognathic maxilla with orthognathic mandible 2.
• Condylar hyperplasia, cleft lip/palate or craniofacial deformities 3.
• CVMI stage greater than 5 4.
• Temporomandibular disorders (TMD) 5.
• History of trauma to the dentofacial region 6.
• Systemic diseases 7.
• Patients on long term medications 8.
• Previous history of orthodontic treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances in conjugation with LIPUS.	6 months
2. To evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances in conjugation with LLLT.	6 months
3. To compare and evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances and in conjugation with LIPUS and LLLT.	6 months

Secondary Outcome Measures

Name	Time	Method
3. To compare and evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances and in conjugation with LIPUS and LLLT.	6 months

Trial Locations

Locations (1)

Sri Hasanamba dental College and Hospital; 🇮🇳 Hassan, KARNATAKA, India

Sri Hasanamba dental College and Hospital

🇮🇳Hassan, KARNATAKA, India

Harish B

Principal investigator

harishbasavaraj22@gmail.com