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Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

Primary Purpose

Open Bite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Rapid molar intruder
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Bite focused on measuring Anterior open bite, Rapid molar intruder, Mixed dentition

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rapid Molar Intruder

Untreated Control Group

Arm Description

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.

Patients in this group will be monitored without any active treatment.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 11, 2022
Last Updated
December 11, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05657522
Brief Title
Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder
Official Title
Short-term Soft and Hard Tissue Changes Following Skeletal Anterior Open Bite Treatment Using the Rapid Molar Intruder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2013 (Actual)
Primary Completion Date
April 20, 2014 (Actual)
Study Completion Date
January 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Bite
Keywords
Anterior open bite, Rapid molar intruder, Mixed dentition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid Molar Intruder
Arm Type
Experimental
Arm Description
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.
Arm Title
Untreated Control Group
Arm Type
No Intervention
Arm Description
Patients in this group will be monitored without any active treatment.
Intervention Type
Device
Intervention Name(s)
Rapid molar intruder
Intervention Description
The rapid molar intruder was applied.
Primary Outcome Measure Information:
Title
Change in the SNA angle
Description
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.
Title
Change in the SNB angle.
Description
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.
Title
Change in the ANB angle
Description
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.
Title
Change in the MM angle
Description
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.
Title
Change in the SN-OCP angle
Description
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.
Title
Change in the SN-MP angle
Description
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.
Title
Change in the SN-SPP angle
Description
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.
Title
Change in the overbite (Ovb)
Description
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.
Title
Change in the overjet (Ovj)
Description
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.
Title
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
Description
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.
Title
Change in the UI- LI angle
Description
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.
Title
Change in the NS-GN angle
Description
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.
Title
Change in the posterior facial height (S-Go)
Description
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.
Title
Change in the anterior facial height (N-Me)
Description
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.
Title
Change in the U1-Palatal plane measurement
Description
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.
Title
Change in the U6-Palatal plane measurement
Description
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.
Title
Change in the L1-GoMe measurement
Description
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.
Title
Change in the L6-GoMe measurement
Description
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.
Secondary Outcome Measure Information:
Title
Change in the Li-Esth measurement
Description
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.
Title
Change in the Ls-Esth measurement
Description
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.
Title
Change in the Nasolabial angle
Description
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.
Title
Change in the Mentolabial angle
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hammam Zeidan, DDS,MSc
Organizational Affiliation
Department of Orthodontics, University of Al-Baath Dental School, Hama, Syria.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amjad A Hasan, DDS,MSc
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Azzam Al-Jundi, DDS,MSc,PhD
Organizational Affiliation
Department of Orthodontics, University of Hama, Dental School, Hama, Syria.
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27615261
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.
Results Reference
background
PubMed Identifier
26846264
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.
Results Reference
background
PubMed Identifier
28488080
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.
Results Reference
background
PubMed Identifier
19915269
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.
Results Reference
background
PubMed Identifier
17605497
Citation
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.
Results Reference
background

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Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

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