Clinical trial NCT03172442: Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance
Official title: Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Keywords: Class III treatment
orthodontic removable traction appliance
RCT
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly assigned to one of the two groups, case or control.
Primary purpose: TREATMENT

Brief summary: This experimental study aims to evaluate the efficiency of the orthodontic removable traction appliance in the treatment of skeletal class III malocclusion. The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and control group. The dentoskeletal changes will be assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm positive overjet.

Detailed description: Treatment of class III malocclusion is a major challenge in orthodontic contemporary practice, Several appliance have suggested for the treatment of class III malocclusion, such as the facial mask and chin cup.

Despite of the efficiency of this extraoral appliance, its external appearance and its big size reduce patients' cooperation which decrease its clinical effects.

Another Class III treatment modality is the Orthodontic Removable Traction Appliance (ORTA). It is a removable appliance that can be used in conjunction with rapid palatal expansion or fixed appliances, It was developed in the 1980's by Dr. David Musich who developed this appliance in order to overcome issues of compliance that Dr. Musich experienced with use of the protraction facemask.

There is only one study that evaluated this appliance which is a retrospective study compared the treatment effects of the ORTA and protraction facemask in treatment of Class III malocclusions. However, this study has a lot of limitations which made it difficult to accurately evaluate the efficiency of this device.

The aim of this study is studying the dentoskeletal changes that result from treatment by this device, by comparing them to the changes in matched untreated group,by studying the cephalometric x-rays.

Eligibility criteria: Inclusion Criteria:

* Patients in early mixed dentation (8-10 years old).
* Skeletal class III caused by maxillary deficiency with or without mandibular prognathism judged clinically and confirmed radiographically(ANB≤1).
* Anterior crossbite on two teeth or more or an edge-to-edge bite.
* Normal inclination of the lower incisors with the mandibular plane.

Exclusion Criteria:

* Poor oral hygiene.
* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Severe skeletal class III primarily resulting from mandibular prognathism (ANB less than - 4)
* Patients with facial asymmetry.
* Patients with vertical growth pattern.

Primary outcomes:
measure: The change of the ANB angle
timeFrame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Secondary outcomes:
measure: The change of the SNA angle
timeFrame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
measure: The change of the SNB angle
timeFrame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
measure: Levels of pain
timeFrame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.
measure: Levels of discomfort
timeFrame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.
measure: Levels of acceptance
timeFrame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Ahmad S Burhan, PhD.
role: STUDY_CHAIR
References:
citation: Cha KS. Skeletal changes of maxillary protraction in patients exhibiting skeletal class III malocclusion: a comparison of three skeletal maturation groups. Angle Orthod. 2003 Feb;73(1):26-35. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
citation: Mandall N, DiBiase A, Littlewood S, Nute S, Stivaros N, McDowall R, Shargill I, Worthington H, Cousley R, Dyer F, Mattick R, Doherty B. Is early Class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 15-month follow-up. J Orthod. 2010 Sep;37(3):149-61. doi: 10.1179/14653121043056.
citation: Gautam P, Valiathan A, Adhikari R. Skeletal response to maxillary protraction with and without maxillary expansion: a finite element study. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):723-8. doi: 10.1016/j.ajodo.2007.06.016.
citation: Turley PK. Orthopedic correction of Class III malocclusion with palatal expansion and custom protraction headgear. J Clin Orthod. 1988 May;22(5):314-25. No abstract available.
citation: Suda N, Ishii-Suzuki M, Hirose K, Hiyama S, Suzuki S, Kuroda T. Effective treatment plan for maxillary protraction: is the bone age useful to determine the treatment plan? Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):55-62. doi: 10.1067/mod.2000.104491.