Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

NCT05657522 | Completed DMC

• 1 other identifier: UDDS-Ortho-17-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Bite

Keywords

Anterior open bite; Rapid molar intruder; Mixed dentition

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Rapid Molar Intruder

EXPERIMENTAL

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

Untreated Control Group

NO INTERVENTION

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

Interventions

Rapid molar intruder DEVICE

The rapid molar intruder was applied.

Rapid Molar Intruder

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Presence of periodontal diseases
• Presence of general diseases, syndromes or cleft lip and palate
• Patients with previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 27615261 BACKGROUND

• 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.

  PMID: 26846264 BACKGROUND

• 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.

  PMID: 28488080 BACKGROUND

• 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.

  PMID: 19915269 BACKGROUND

• 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.

  PMID: 17605497 BACKGROUND

MeSH Terms

Conditions

Open Bite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hammam Zeidan, DDS,MSc

  Department of Orthodontics, University of Al-Baath Dental School, Hama, Syria.

  PRINCIPAL INVESTIGATOR

• Amjad A Hasan, DDS,MSc

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Azzam Al-Jundi, DDS,MSc,PhD

  Department of Orthodontics, University of Hama, Dental School, Hama, Syria.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 20, 2022
• Study Start: September 25, 2013
• Primary Completion: April 20, 2014
• Study Completion: January 20, 2015
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)