Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion
Condition: Class III Malocclusion; Cross Bite; Orthodontic Appliance Complication
MeSH terms: Prognathism; Malocclusion; Malocclusion, Angle Class III
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the levels of pain, discomfort and acceptance between
      two treatment modalities of Class III correction of growing patients in the late mixed
      dentition period.
    

Detailed description: 
      The acceptance of orthodontic appliance is measured by the amount of discomfort occurring
      during orthodontic treatment. Different feelings can be encountered during the course of
      orthodontic treatment such as pressure, tension and pain. Pain is defined as an unpleasant
      feeling and a bad subjective experience combined with internal or external reason and it is
      considered as the most annoying factor during orthodontic treatment with fixed appliance. In
      a study by Oliver and Knappman, patients stated that the worse thing related to the
      orthodontic treatment was pain and 70% of the subjects suffered from pain during orthodontic
      treatment regardless the appliance' type. The fear from the pain is considered as the most
      important factor that not encourage patient to ask orthodontic treatment.Many studies
      demonstrated that there were no differences in the amount of the pain resulted from the
      orthodontic treatment between males and females [2, 5]. In a study of the reasons which make
      patient stopped the orthodontic treatment, Haynes found that the pain was the first reason,
      whereas the second one was the effect of the orthodontic appliance on the patient's daily
      social life.

      When reviewing the medical literature, few studies have been found to identify the patient
      acceptance degree to the orthodontic appliance used for treating Class III cases in general
      and Class III functional appliances in particular.Removable appliances were evaluated by a
      series of publications by Sergl et al in Germany.Additionally, when rigorous study designs
      are considered utilizing randomized controlled trials (RCTs), there are only few RCTs in the
      dental literature that evaluated patients' responses towards orthodontic treatment. Idris et
      al., evaluated Class II growing patients undergoing functional orthopedic corrections,
      whereas Khattab et al., compared labial brackets versus lingual brackets in terms of speech
      and functional impairments. Recently, Saleh et al., evaluated the levels of acceptance
      towards the removable mandibular retractor (RMR) when treating young children with Class III
      malocclusion in the late primary dentition and early mixed dentition (i.e. between 5 and 9
      years) and found high levels of acceptance recommending the need for further analysis of
      patients' responses to this appliance in older age groups.

      Bone-anchored intermaxillary elastics have been proposed as a method of correcting Class III
      deformities. Although this method was compared to the removable mandibular retractor in terms
      of skeletal and dentoalveolar changes, but the published paper did not report any information
      about the associated levels of pain and discomfort as well the general acceptability to this
      treatment modality.
    

Intervention name(s): Removable Mandibular Retractor; Bone-anchored intermaxillary traction
Intervention type(s): Device; Device
Intervention description(s): The appliance will be used 18 hours per day. It can only be removed for eating meals.; The patients will be instructed to wear the upper removable appliance for 18 hours per day. The elastics should be extended from the upper appliance towards the lower mini-screws.
Other intervention name(s): RMR; Inferiorly extended labial bow; Reverse Hawley bow; BAIMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Removable Mandibular Retractor; Bone-anchored Intermaxillary Traction