Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

NCT ID: NCT05657522

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-25

Study Completion Date

2015-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Bite

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anterior open bite Rapid molar intruder Mixed dentition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rapid molar intruder

Intervention Type DEVICE

The rapid molar intruder was applied.

Untreated Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rapid molar intruder

The rapid molar intruder was applied.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damascus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hammam Zeidan, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

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

Amjad A Hasan, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics, Damascus University, Syria

Mohammad Y. Hajeer, DDS,MSc,PhD

Role: STUDY_DIRECTOR

Department of orthodontics, Damascus University, Syria

Azzam Al-Jundi, DDS,MSc,PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Damascus

Damascus, , Syria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Syria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27615261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26846264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28488080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19915269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17605497 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDDS-Ortho-17-2022

Identifier Type: -

Identifier Source: org_study_id