Class II MalocclusionNCT05647720
Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients
A study testing Distalization combined with upper third molars extraction and Distalization without upper third molars extraction in people with Class II Malocclusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Distalization combined with upper third molars extraction and Distalization without upper third molars extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2021to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- skeletal Class II or Class III relationship.
- past orthodontic treatment.
- poor oral hygiene.
- Increased vertical dimension.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the detailed description
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.
- Conditions
- Class II Malocclusion
- Being tested
- Distalization combined with upper third molars extraction, Distalization without upper third molars extraction
- Keywords
- Infra-zygomatic mini-implant, Distalization, Infra-zygomatic crest, Digital models, molar tipping
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distalization combined with upper third molars extractionProcedure or surgery
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 extractionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Third molar extraction group | Experimental | After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest. Receives: Procedure: Distalization combined with upper third molars extraction |
| Third molar presence group | Experimental | Without extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest. Receives: Procedure: Distalization without upper third molars extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
distalization amount of maxillary firs molars at the crown and root levels
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)
Measured: From pre to post distalization (an average of 8 months)
Secondary outcomes (12)
Rate of maxillary first molar Distalization
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)
Measured: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary first molar
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).
Measured: From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary first molar
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)
Measured: From pre- to post-distalization (an average of 8 months)
Inter molar width
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)
Measured: From pre- to post-distalization (an average of 8 months)
Molar rotation
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)
Measured: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary second molar
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)
Measured: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary third molar
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)
Measured: From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary third molar
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)
Measured: From pre- to post-distalization (an average of 8 months)
Vertical position of upper incisors
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)
Measured: From pre- to post-distalization (an average of 8 months)
Anteroposterior position of upper incisors
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)
Measured: From pre- to post-distalization (an average of 8 months)
upper incisors torque
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)
Measured: From pre- to post-distalization (an average of 8 months)
Anteroposterior changes of upper first and second premolars
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)
Measured: From pre- to post-distalization (an average of 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start28 Feb 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadeen Hafez, Future University in Egypt
- Investigators
- Yehya Mostafa, Professor and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647720
- Sponsor's protocol ID
- FUE.REC(14)/7-2019
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05647720
- Acronym / sponsor ID
- FUE.REC(14)/7-2019
- Conditions
- Class II Malocclusion
- Keywords
- Infra-zygomatic mini-implant, Distalization, Infra-zygomatic crest, Digital models, molar tipping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Third molar extraction group | Experimental | Procedure: Distalization combined with upper third molars extractionAfter surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest. |
| Third molar presence group | Experimental | Procedure: Distalization without upper third molars extractionWithout extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- skeletal Class II or Class III relationship.
- past orthodontic treatment.
- poor oral hygiene.
- Increased vertical dimension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distalization combined with upper third molars extractionAfter 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 | Procedure or surgery | Third molar extraction group |
| Distalization without upper third molars extractionThe 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 | Procedure or surgery | Third molar presence group |
Primary outcome
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)
12 secondary outcomes
Rate of maxillary first molar Distalization
Time frame: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary first molar
Time frame: From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary first molar
Time frame: From pre- to post-distalization (an average of 8 months)
Inter molar width
Time frame: From pre- to post-distalization (an average of 8 months)
Molar rotation
Time frame: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary second molar
Time frame: From pre- to post-distalization (an average of 8 months)
Tipping of maxillary third molar
Time frame: From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary third molar
Time frame: From pre- to post-distalization (an average of 8 months)
Vertical position of upper incisors
Time frame: From pre- to post-distalization (an average of 8 months)
Anteroposterior position of upper incisors
Time frame: From pre- to post-distalization (an average of 8 months)
upper incisors torque
Time frame: From pre- to post-distalization (an average of 8 months)
Anteroposterior changes of upper first and second premolars
Time frame: From pre- to post-distalization (an average of 8 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Yes. All collected participant data (IPD)
Related trials for Class II Malocclusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehya Mostafa, Professor and Chairman study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distalization combined with upper third molars extraction and Distalization without upper third molars extraction in people with Class II Malocclusion, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distalization amount of maxillary firs molars at the crown and root levels (time frame: From pre to post distalization (an average of 8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.