Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

Study Overview
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Brief Summary
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This study evaluated the efficacy of rapid molar intruder (RMI) in treating anterior open bite in the mixed dentition. The study sample consisted of 40 patients who had a skeletal anterior open bite. The sample was allocated randomly into two groups: the RMI group and the control group. The skeletal, dentoalveolar and soft tissue changes occurring after treatment were assessed by using lateral cephalometric images.

Detailed Description
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Many appliances have been used to treat skeletal anterior open bite (AOB) malocclusion, such as removable appliances, extra-oral appliances (vertical chin cup and vertical head gear), fixed appliances, Orthognathic surgery and functional appliances. Treatment with these appliances produces soft and hard dentofacial tissue changes. Many studies have been carried out in order to study these changes. In this study, the investigators treated AOB using RMI. Patients were divided into two groups to evaluate the efficacy of RMI. RMI group: Rapid molar intruder was applied. Control group: Untreated control group. In order to evaluate the changes occurring, lateral cephalometric images were taken in both groups at the beginning of the treatment (T1) and after 9 months of the first cephalograms (T2).

Official Title
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Short-term Soft and Hard Tissue Changes Following Skeletal Anterior Open Bite Treatment Using the Rapid Molar Intruder

Conditions
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Open Bite

Intervention / Treatment
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* Device: Rapid molar intruder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the mixed dentition Chronological age between 8 and 12 years skeletal class I or II malocclusion Skeletal anterior open bite was assessed clinically and then confirmed radiographically: SN/GoMe was greater than 33°, MM was greater than 27 No general problems Good oral health Exclusion Criteria: Presence of periodontal diseases Presence of general diseases, syndromes or cleft lip and palate Patients with previous orthodontic treatment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Molar Intruder<br>Patients in this group will undergo the interventional procedure, which is the application of the rapid molar intruder appliance. This will help in correcting the open bite. | Device: Rapid molar intruder<br>* The rapid molar intruder was applied.<br>|
| No Intervention: Untreated Control Group<br>Patients in this group will be monitored without any active treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the SNA angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the SNB angle. | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the ANB angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the MM angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the SN-OCP angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the SN-MP angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the SN-SPP angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the overbite (Ovb) | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the overjet (Ovj) | Lateral cephalometric images were taken for each patient. This was measured in millimetres Horizontally from the upper to the lower central incisors. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me) | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the UI- LI angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper and the lower incisor axis in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the NS-GN angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the posterior facial height (S-Go) | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from S point to GO point. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the anterior facial height (N-Me) | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from N point to Me point. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the U1-Palatal plane measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper central incisor apex and the palatal plane. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the U6-Palatal plane measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the upper first molar and the palatal plane. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the L1-GoMe measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the lower central incisor apex and the mandibular plane. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the L6-GoMe measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the tip of the mesial cusp of the lower first molar and the mandibular plane. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Li-Esth measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the Ls-Esth measurement | Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the Nasolabial angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 
| Change in the Mentolabial angle | Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction. | Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior open bite, Rapid molar intruder, Mixed dentition