Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

Not Applicable

Completed

• Conditions: Open Bite
• Interventions: Device: Rapid molar intruder

• Registration Number: NCT05657522
• Lead Sponsor: Damascus University

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-09-25
• Primary Completion: 2014-04-20
• Study Completion: 2015-01-20
• Status Verified: 2022-12
• Study First Submitted: 2022-12-11
• Study First Submitted QC: 2022-12-11
• Last Update Submitted: 2022-12-11
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients in the mixed dentition
2. Chronological age between 8 and 12 years
3. skeletal class I or II malocclusion
4. Skeletal anterior open bite was assessed clinically and then confirmed radiographically: SN/GoMe was greater than 33°, MM was greater than 27
5. No general problems
6. Good oral health

Exclusion Criteria

1. Presence of periodontal diseases
2. Presence of general diseases, syndromes or cleft lip and palate
3. Patients with previous orthodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Molar Intruder	Rapid molar intruder	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.

Primary Outcome Measures

Name	Time	Method
Change in the SN-OCP angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the SNB angle.	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the MM angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the SN-MP angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the NS-GN angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the anterior facial height (N-Me)	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from N point to Me point.
Change in the ANB angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the overbite (Ovb)	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Change in the SNA angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Change in the UI- LI angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the posterior facial height (S-Go)	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from S point to GO point.
Change in the U1-Palatal plane measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper central incisor apex and the palatal plane.
Change in the U6-Palatal plane measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the overjet (Ovj)	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres Horizontally from the upper to the lower central incisors.
Change in the SN-SPP angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the L1-GoMe measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the lower central incisor apex and the mandibular plane.
Change in the L6-GoMe measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Li-Esth measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.
Change in the Nasolabial angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.
Change in the Ls-Esth measurement	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.
Change in the Mentolabial angle	Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.	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.

Trial Locations

Locations (1)

University of Damascus; 🇸🇾 Damascus, Syrian Arab Republic