Clinical Trial: Evaluation of Mini Plates Anchorage With Forsus Fatigue Resistant Device

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of Mini Plates Anchorage in Conjunction With Forsus Fatigue Resistant Device for Correction of Skeletal Class II Malocclusion in Growing Subjects: A Randomized

Brief Summary: The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular effects while preventing the excessive proclination of the lower incisors at the end of the treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied to the upper and lower dental arches in female patients with skeletal Class II malocclusion

Detailed Summary:

  1. Background:

    Class II malocclusions are characterized by an incorrect relationship between the maxillary and mandibular arches due to skeletal or dental problems or a combination of both. The prevalence of this malocclusion was recently found to be 20.6% in the Egyptian population in the age between 11 and 14 years with mandibular retrusion as its most common characteristic. It was also mentioned that other populations showed the predominance of the mandibular retrusion (80%) as opposed to only 20% expressing excessive maxillary development.

    Class II profiles attractiveness was previously investigated in the literature. It was found that patients, their peers, orthodontists and oral surgeons, rated subjects with Class I profiles as more attractive than others with Class II profiles. It was also reported that the profile of normal adolescent patients were more favorably perceived by laypersons than untreated Class II division 1 malocclusion subjects.

    In growing patients having Class II mandibular retrusion, functional orthopedic appliances are commonly used for mandibular advancement based on the concept of growth modification. However, two main problems appeared to compromise the desired treatment outcomes of these appliances; the need for patient cooperation and the lack of the possibility of combining their use with fixed appliance therapy in order to shorten treatment duration.

    Many systematic reviews and meta-analyses were recently performed in the literature answering the question of whether removable functional appliances (RFAs) produced skeletal effects for correction the skeletal discrepancy through inducing actual increase in mandibular di
    Sponsor: Sherif A. Elkordy

    Current Primary Outcome: correction of the skeletal Class II profile [ Time Frame: expected average of 10 months ]

    This outcome will be detected through measurement of the mean change in the effective mandibular length and position from baseline data that when increased will result in a decrease in profile convexity. This measurement will be done after FFRD removal and correction of the sagittal relationship.

    Cone-beam computed tomography (CBCT) images will be used for analysis of this outcome where changes in effective mandibular length (Co-Gn) will be measured in mm



    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Dento-alveolar side effects [ Time Frame: expected average of 10 months ]
      The dento-alveolar side effects of the appliance therapy are to be detected. CBCT images will be used for analysis of this outcome where changes in the inclination and positions of incisors will be measured in degrees and mm respectively.
    • Angle of soft tissue convexity [ Time Frame: expected average of 10 months ]
      Changes in the soft tissue angle of convexity will be detected by CBCT (in degrees) that contribute to soft tissue profile correction
    • Position of lips and Chin [ Time Frame: expected average of 10 months ]
      Will be detected by CBCT; the position of the upper and lower lips and chin will be measured in mm relative to a frontal plane


    Original Secondary Outcome: Same as current

    Information By: Cairo University

    Dates:
    Date Received: June 13, 2015
    Date Started: January 2015
    Date Completion: December 2016
    Last Updated: January 26, 2016
    Last Verified: January 2016