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NCT Number: NCT05647720

Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients

There is a scarcity in literature regarding the influence of maxillary third molar on distalization . This study aimed to compare the influence of unerupted maxillary third molars and their extraction on the bilateral distalization of upper first molars using the infra-zygomatic gear distalizer

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

16 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, Egypt

About this study

Maxillary molar distalization is one of the non-extraction modalities for treating class II malocclusion. When distalizing maxillary molars In adults, it is not a problem to extract fully erupted third molars, and it may even be suggested that the extraction site may accommodate distalization. On the contrary, adolescents usually have unerupted third molars with partially formed roots, rendering the surgical extraction more difficult and traumatic. The necessity of surgically extracting upper third molar buds before distalization remains questionable. Therefore, this study was conducted to three-dimensionally assess the impact of maxillary third molar presence on distalizing maxillary molars in adolescent patients having Class II malocclusion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adolescent patients aged 16-19 years
  • skeletal Class I
  • bilateral Class II molar relationship. defined by at least an end-to-end molar relationship.
  • normal vertical growth pattern.
  • full permanent dentition with unerupted upper third molars.

Exclusion criteria

  • skeletal Class II or Class III relationship.
  • past orthodontic treatment.
  • poor oral hygiene.
  • Increased vertical dimension.

Treatment and study plan

Distalization combined with upper third molars extraction

Procedure

After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Distalization without upper third molars extraction

Procedure

The maxillary first molars were distalized , without extracting upper third molars, using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Primary outcomes

  1. distalization amount of maxillary firs molars at the crown and root levels

    Time frame: From pre to post distalization (an average of 8 months)

    Anteroposterior changes in the position of maxillary first molars assessed on digitized models and cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measured in mm)

Secondary outcomes

  1. Rate of maxillary first molar Distalization

    Time frame: From pre- to post-distalization (an average of 8 months)

    Incremental changes in the antero-posterior position of maxillary first molars assessed on digitized models taken for each patient before and after distalization and in each follow up visit. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

  2. Tipping of maxillary first molar

    Time frame: From pre- to post-distalization (an average of 8 months)

    Angular changes of maxillary first molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measurement of the angles in degrees).

  3. Vertical position of maxillary first molar

    Time frame: From pre- to post-distalization (an average of 8 months)

    vertical positional changes of maxillary first molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

  4. Inter molar width

    Time frame: From pre- to post-distalization (an average of 8 months)

    Changes in the transvers distance between the right and left upper first molars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

  5. Molar rotation

    Time frame: From pre- to post-distalization (an average of 8 months)

    Study models that are taken pre and post retraction (then digitalized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)

  6. Tipping of maxillary second molar

    Time frame: From pre- to post-distalization (an average of 8 months)

    Angular changes of maxillary second molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes. (measured in of in degrees)

  7. Tipping of maxillary third molar

    Time frame: From pre- to post-distalization (an average of 8 months)

    Angular changes of maxillary third molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)

  8. Vertical position of maxillary third molar

    Time frame: From pre- to post-distalization (an average of 8 months)

    Vertical positional changes of maxillary third molar assessed on cone beam computed (measured in mm)tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks

    , reference lines, and planes (measured in mm)

  9. Vertical position of upper incisors

    Time frame: From pre- to post-distalization (an average of 8 months)

    Vertical positional changes of upper incisors assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

  10. Anteroposterior position of upper incisors

    Time frame: From pre- to post-distalization (an average of 8 months)

    Antero-posterior change in the anteroposterior position of upper incisors assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

  11. upper incisors torque

    Time frame: From pre- to post-distalization (an average of 8 months)

    Angular changes of upper incisors assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)

  12. Anteroposterior changes of upper first and second premolars

    Time frame: From pre- to post-distalization (an average of 8 months)

    Antero-posterior change in the position of maxillary first and second premolars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Effect of Maxillary Third Molar Extraction vs Non-extraction on Distalization of First Molars in a Group of Adolescent Patients Using Infra-Zygomatic Gear Distalizer: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2022
Registry last updated
Dec 12, 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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