Clinical trial NCT05657522: 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
Overall status: COMPLETED
Phase: NA
Conditions: Open Bite
Keywords: Anterior open bite
Rapid molar intruder
Mixed dentition
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the SNA angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the SNB angle.
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the ANB angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the MM angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the SN-OCP angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the SN-MP angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the SN-SPP angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the overbite (Ovb)
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the overjet (Ovj)
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the UI- LI angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the NS-GN angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the posterior facial height (S-Go)
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the anterior facial height (N-Me)
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the U1-Palatal plane measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the U6-Palatal plane measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the L1-GoMe measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the L6-GoMe measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Secondary outcomes:
measure: Change in the Li-Esth measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the Ls-Esth measurement
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the Nasolabial angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
measure: Change in the Mentolabial angle
timeFrame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of Orthodontics, University of Al-Baath Dental School, Hama, Syria.
name: Hammam Zeidan, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Amjad A Hasan, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y. Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics, University of Hama, Dental School, Hama, Syria.
name: Azzam Al-Jundi, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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.