Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

Open Bite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657522
• Other study ID #: UDDS-Ortho-17-2022
• Status: Completed
• Phase: N/A
• Start date: September 25, 2013
• Est. completion date: January 20, 2015

Study information

• Verified date: December 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 20, 2015
• Est. primary completion date: April 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Open Bite

Intervention

Device:
• Rapid molar intruder
The rapid molar intruder was applied.

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

Cinsar A, Alagha AR, Akyalcin S. Skeletal open bite correction with rapid molar intruder appliance in growing individuals. Angle Orthod. 2007 Jul;77(4):632-9. doi: 10.2319/071406-292. — View Citation

Feres MF, Abreu LG, Insabralde NM, de Almeida MR, Flores-Mir C. Effectiveness of open bite correction when managing deleterious oral habits in growing children and adolescents: a systematic review and meta-analysis. Eur J Orthod. 2017 Feb;39(1):31-42. doi: 10.1093/ejo/cjw005. Epub 2016 Feb 3. — View Citation

Meibodi SE, Fatahi Meybodi S, Samadi AH. The effect of posterior bite-plane on dentoskeletal changes in skeletal open-bite malocclusion. J Indian Soc Pedod Prev Dent. 2009 Oct-Dec;27(4):202-4. doi: 10.4103/0970-4388.57653. — View Citation

Pisani L, Bonaccorso L, Fastuca R, Spena R, Lombardo L, Caprioglio A. Systematic review for orthodontic and orthopedic treatments for anterior open bite in the mixed dentition. Prog Orthod. 2016 Dec;17(1):28. doi: 10.1186/s40510-016-0142-0. Epub 2016 Sep 19. — View Citation

Turkkahraman H, Cetin E. Comparison of two treatment strategies for the early treatment of an anterior skeletal open bite : Posterior bite block-vertical pull chin cup (PBB-VPC) vs. posterior bite block-high pull headgear (PBB-HPH). J Orofac Orthop. 2017 Jul;78(4):338-347. doi: 10.1007/s00056-017-0095-z. Epub 2017 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.