An interventional study of Removable Mandibular Retractor and Bone-anchored intermaxillary traction in Class III Malocclusion, Cross Bite and Orthodontic Appliance Complication, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 38 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients in this group will be treated by the Removable Mandibular Retractor (RMR) in order to get rid of the anterior cross bite. This appliance is removable.
Device: Removable Mandibular Retractor
Patients will be treated using bone-anchored intermaxillary traction. Class III elastics will be extended from the Adam's clasps placed in the upper removable appliance towards the heads of mini-implants placed between the permanent canine and lateral incisors on either side of the lower dental arch.
Device: Bone-anchored intermaxillary traction
The appliance will be used 18 hours per day. It can only be removed for eating meals.
Also known as: RMR, Inferiorly extended labial bow, Reverse Hawley bow
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.
Also known as: BAIMT
Change in the sensation of tension or pressure
Patients will be asked this question about their sensation of tension or pressure (Item no 01): Do you have a sense of tension and pressure in your soft tissues? A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Change in the perception of pain
Patients will be asked this question about their perception of pain (Item no 02): 'Have you experienced any degree of pain?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Change in the perception of speech
Patients will be asked this question about any change encountered in the articulation of sounds (Item no 03): 'Do you feel that your articulation has changed?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Change in swallowing ability
Patients will be asked this question about any difficulties encountered during swallowing (Item no 04): 'Do you have difficulty in swallowing?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Change in mandibular restriction
Patients will be asked this question about any restrictions encountered in lower jaw movements (Item no 05): 'Do you have a sense of your mandible movement being restricted?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Change in self-confidence perception
Patients will be asked this question about their feelings when meeting other people regarding self-confidence (Item no 06): 'Do you have any feeling of embarrassment or lack of confidence?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time frame: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Malocclusion, Angle Class III →