An interventional study of Rapid molar intruder in Open Bite, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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).
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 40 is above the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
Patients in this group will be monitored without any active treatment.
The rapid molar intruder was applied.
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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
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 frame: 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 frame: 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 frame: 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 frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Plan to share: No
Ran from Sep 2013 to primary completion in Apr 2014, 6 months.
Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 6 months is below that.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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