Treatment of growing individuals with small lower jaw using appropriate fixed functional appliances.

Completed

• Conditions: Other specified disorders of teethand supporting structures,

• Registration Number: CTRI/2021/01/030399
• Lead Sponsor: Director General Armed Forces Medical Services

Brief Summary

Fixed functional appliances are used for correction of skeletal Class II malocclusion with retrognathic mandible in growing patients. In patients who report after the pubertal growth spurt or during late stages of puberty with minimal growth left, fixed functional appliances are a treatment of choice. They are often called "non-complaint Class II correctors" as they require minimum patient co-operation unlike removable appliances. The Forsus FRD (3M Unitek Corp., Monrovia, Calif) is one of the most commonly used fixed functional appliance for correction of class II malocclusion. But it is often associated with limitations like frequent breakage of canine brackets and soft tissue lacerations. It is available in various sizes, hence a large inventory must be maintained and chairside time is increased as correct size for individual patient needs to be selected. The AdvanSync 2 is the latest addition to the orthodontist’s armamentarium. It comprises of several modifications in the original AdvanSync appliance to deliver latest, simple and efficient Class II correction. A bonus that came out of this new smaller design of this appliance was the ability to bracket every tooth anterior to this appliance that has allowed orthopaedic correction along with simultaneous orthodontic correction resulting in reduced treatment time by almost 06 months in correction of malocclusion. Apart from few case reports there is no published study which compares the AdvanSync2 appliance with FORSUS FRD appliance. Thus, the purpose of this pilot study is to evaluate clinical efficacy of AdvanSync2 appliance in the treatment of skeletal class II malocclusion and compare with FORSUS FRD. The null hypothesis is that there is no significant difference in treatment effects between Forsus and AvanSync2.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study Completion: 2023-07-31
• Last Update Posted: 2023-08-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Cases of Class II malocclusion (ANB>4 degrees) 2.
• Molar relation class II/Half cusp class II 3.
• Overjet > 4mm 4.
• Positive Visual Treatment Objective 5.
• CVMI stage III-VI 6.
• No missing or supernumerary teeth 7.
• Patients giving written consent to participate in the study 8.
• No h/o previous orthodontic treatment/trauma to jawbones.

Exclusion Criteria

1.Negative VTO 2.History of previous orthodontic treatment 3.Systemic diseases affecting bone metabolism 4.Patients with neuromuscular disorders & TMJ problems 5.Insufficient teeth/periodontal status to support the appliance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correction of Skeletal Class II malocclusion	After completion of treatment

Secondary Outcome Measures

Name	Time	Method
a)To compare treatment duration between the study groups.	b)To compare chairside time taken for appliance insertion and removal between the study groups.

Trial Locations

Locations (2)

Armed Forces Medical College; 🇮🇳 Pune, MAHARASHTRA, India

Army Dental Centre Research and Referral; 🇮🇳 Delhi, DELHI, India

Armed Forces Medical College

🇮🇳Pune, MAHARASHTRA, India

Lt Col Vishvaroop

Principal investigator

9596957766

vrnagpal_1008@yahoo.co.in