Third Molar ImpactionNCT06098885
The Effect of Different Treatment Modalities of Class II Malocclusion on Upper Third Molars.
An observational study of Third Molar Impaction, run by Cairo University at 1 site in Egypt.
Trial summary
What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars? Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Molar Impaction
- What is being tested?
- extraction orthodontic treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2021to 4 Jun 2023
- Phase
- Observational
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: • Egyptian Adolescent males and females (16 -18 years)
Who may be able to join
- Adolescent males and females (16 -18 years) with Bilaterally developing maxillary third molars. Not more than two thirds of the root development of the third molars had taken place.
- Class II malocclusion cases that were treated by 1) maxillary premolar extraction with a moderate anchorage requirement and achieved full unit class II molar relationship or 2) Distalization treatment plan and class I molar relationship was achieved.
- Patients with high-quality pre- and post-treatment radiographs.
- Normal or increased vertical dimension.
Who cannot join
- Maxillary Premolar extraction cases requiring maximum anchorage preparation.
- Low vertical dimension.
- Patients without dentofacial deformities, severe facial asymmetries, microdontia or hypodontia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Treatment Modalities of Class II Malocclusion on Upper Third Molars: A Retrospective Longitudinal Study
What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars?
Read the detailed description
What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars? Pico P: Adolescent patients with class II malocclusion having bilateral developing upper third molars.
I: bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.
C: distalization orthodontic treatment. O: Primary: angulation of the maxillary third molars.
- Conditions
- Third Molar Impaction
- Being tested
- extraction orthodontic treatment
- Keywords
- distalization, premolar extraction, upper third molar, impaction of third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraction orthodontic treatmentOther
bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.
| Study group | Role | What they receive |
|---|---|---|
| extraction treatment | patients treated with bilateral upper first premolar extraction orthodontic treatment with moderate anchorage. Receives: Other: extraction orthodontic treatment | |
| distalization treatment | patients treated by distalization orthodontic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The angulation of the maxillary third molars.
the angle between the long axis of the third molar and the palatal plane
Measured: up to 24 weeks.
Secondary outcomes (2)
The vertical position of the third molars
the vertical position of the third molar relative to the second molar measured using Archer classification tool. (qualitative measure)
Measured: up to 24 weeks
The mineralization status of the third molars
the amount of calcified tissues of the third molar measured using Demirjian classification method
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start4 Sep 2021
- Primary completion4 Jun 2023
- Study completion4 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar ImpactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Aboalnaga, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098885
- Sponsor's protocol ID
- CEBD-CU-2021-9-7
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Treatment Modalities of Class II Malocclusion on Upper Third Molars: A Retrospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT06098885
- Acronym / sponsor ID
- CEBD-CU-2021-9-7
- Conditions
- Third Molar Impaction
- Keywords
- distalization, premolar extraction, upper third molar, impaction of third molar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 25 Oct 2023 (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.
What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars?
Detailed description
What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars? Pico P: Adolescent patients with class II malocclusion having bilateral developing upper third molars.
I: bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.
C: distalization orthodontic treatment. O: Primary: angulation of the maxillary third molars.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extraction treatment | – | Other: extraction orthodontic treatmentpatients treated with bilateral upper first premolar extraction orthodontic treatment with moderate anchorage. |
| distalization treatment | – | –patients treated by distalization orthodontic treatment. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- • Egyptian Adolescent males and females (16 -18 years)
Key inclusion criteria (4 listed)
- Adolescent males and females (16 -18 years) with Bilaterally developing maxillary third molars. Not more than two thirds of the root development of the third molars had taken place.
- Class II malocclusion cases that were treated by 1) maxillary premolar extraction with a moderate anchorage requirement and achieved full unit class II molar relationship or 2) Distalization treatment plan and class I molar relationship was achieved.
- Patients with high-quality pre- and post-treatment radiographs.
- Normal or increased vertical dimension.
Key exclusion criteria (3 listed)
- Maxillary Premolar extraction cases requiring maximum anchorage preparation.
- Low vertical dimension.
- Patients without dentofacial deformities, severe facial asymmetries, microdontia or hypodontia.
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 |
|---|---|---|
| extraction orthodontic treatmentbilateral upper first premolar extraction orthodontic treatment with moderate anchorage. | Other | extraction treatment |
Primary outcome
The angulation of the maxillary third molars.
Time frame: up to 24 weeks.
the angle between the long axis of the third molar and the palatal plane
2 secondary outcomes
The vertical position of the third molars
Time frame: up to 24 weeks
The mineralization status of the third molars
Time frame: up to 24 weeks
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 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Third Molar Impaction, run by Cairo University 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 4 inclusion and 3 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 25 Oct 2023. 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?
The angulation of the maxillary third molars. (time frame: up to 24 weeks.). 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 25 Oct 2023.