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Completed

NCT Number: NCT05657522

Early Treatment of Anterior Open Bite Using the Rapid Molar Intruder

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.

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Key information

Conditions

Open Bite Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid molar intruder

Device

The rapid molar intruder was applied.

Primary outcomes

  1. Change in the SNA angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  2. Change in the SNB angle.

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  3. Change in the ANB angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  4. Change in the MM angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  5. Change in the SN-OCP angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  6. Change in the SN-MP angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  7. Change in the SN-SPP angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  8. Change in the overbite (Ovb)

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.

  9. Change in the overjet (Ovj)

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres Horizontally from the upper to the lower central incisors.

  10. Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.

  11. Change in the UI- LI angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  12. Change in the NS-GN angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  13. Change in the posterior facial height (S-Go)

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from S point to GO point.

  14. Change in the anterior facial height (N-Me)

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from N point to Me point.

  15. Change in the U1-Palatal plane measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper central incisor apex and the palatal plane.

  16. Change in the U6-Palatal plane measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  17. Change in the L1-GoMe measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the lower central incisor apex and the mandibular plane.

  18. Change in the L6-GoMe measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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 outcomes

  1. Change in the Li-Esth measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.

  2. Change in the Ls-Esth measurement

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.

  3. Change in the Nasolabial angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

  4. Change in the Mentolabial angle

    Time frame: Time 1: One week before the beginning of the treatment, Time 2: after nine months from the beginning of active treatment.

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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