Orthodontic Treatment Via Premolar ExtractionNCT04857658
Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars
A study testing extraction orthodontic treatment plan in people with Orthodontic Treatment Via Premolar Extraction, run by Cairo University at 1 site in Egypt.
Trial summary
What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars? Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment Via Premolar Extraction
- What is being tested?
- extraction orthodontic treatment plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2021to 10 Dec 2023
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.
- Dental Class I malocclusion cases requiring four premolar extraction with a moderate anchorage requirement.
- low or increased vertical dimension.
Who cannot join
- Premolar extraction cases requiring maximum anchorage preparation.
- Low vertical dimension.
- patients without dentofacial deformities, severe facial asymmetries, or missing teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars: A Non-Randomized Clinical Trial /a Prospective Clinical Trial
What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?
Read the detailed description
Data regarding the personal information (name, age and gender), chief complaint, medical and dental history will be taken. Medical history questionnaire will be filled by the patient to exclude the presence of any systemic conditions.
complete set of orthodontic records will be taken; Pre- operative records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram). After formulating the best treatment plan for each patient, All patients will be enrolled into one of two groups: Intervention Group (I) : Extraction treatment group. Comparator group (C): Non-extraction group. Following the end of treatment, Post-treatment records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram) will be taken.
Primary outcome: The angulation of the mandibular third molars.Secondary outcomes:
- space available for the upper and lower third molar.
- Angulation of the third molar.
- The vertical position of the third molars.
- the mineralization status of the third molars
- Being tested
- extraction orthodontic treatment plan
- Keywords
- third molar impaction, third molar angulation, third molar vertical position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraction orthodontic treatment planProcedure or surgery
patients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow.
| Study group | Role | What they receive |
|---|---|---|
| extraction treatment | Active comparator | patients will be referred for extraction of the upper and lower first premolars to relieve the crowding. Receives: Procedure: extraction orthodontic treatment plan |
| non-extraction treatment | No intervention | Leveling and alignment of the moderate crowding will be performed through a recall visits of 4 weeks for wire activation. inter-proximal reduction step might be done if needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
third molar angulation
The angulation of the mandibular third molars
Measured: at the end of orthodontic treatment
Secondary outcomes (4)
space available for the upper and lower third molar
space available for the upper and lower third molar
Measured: at the end of orthodontic treatment
Angulation of the third molar.
Angulation of the third molar.
Measured: at the end of orthodontic treatment
The vertical position of the third molars
The vertical position of the third molars
Measured: at the end of orthodontic treatment
the mineralization status of the third molars
the mineralization status of the third molars
Measured: at the end of orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start4 Jan 2021
- Primary completion4 Mar 2023
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Treatment Via Premolar ExtractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Aboalnaga, Cairo University
- Investigators
- amira aboalnaga, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857658
- Sponsor's protocol ID
- CEBD-CU-2021-10-4
- Status last verified
- Sep 2023
- First submitted
- 20 Apr 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the pre-treatment and post-treatment records
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars: A Non-Randomized Clinical Trial /a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04857658
- Acronym / sponsor ID
- CEBD-CU-2021-10-4
- Keywords
- third molar impaction, third molar angulation, third molar vertical position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 23 Apr 2021 (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 extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?
Detailed description
Data regarding the personal information (name, age and gender), chief complaint, medical and dental history will be taken. Medical history questionnaire will be filled by the patient to exclude the presence of any systemic conditions.
complete set of orthodontic records will be taken; Pre- operative records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram). After formulating the best treatment plan for each patient, All patients will be enrolled into one of two groups: Intervention Group (I) : Extraction treatment group. Comparator group (C): Non-extraction group. Following the end of treatment, Post-treatment records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram) will be taken.
Primary outcome: The angulation of the mandibular third molars.Secondary outcomes:
- space available for the upper and lower third molar.
- Angulation of the third molar.
- The vertical position of the third molars.
- the mineralization status of the third molars
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extraction treatment | Active comparator | Procedure: extraction orthodontic treatment planpatients will be referred for extraction of the upper and lower first premolars to relieve the crowding. |
| non-extraction treatment | No intervention | –Leveling and alignment of the moderate crowding will be performed through a recall visits of 4 weeks for wire activation. inter-proximal reduction step might be done if needed. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.
Key exclusion criteria (3 listed)
- Premolar extraction cases requiring maximum anchorage preparation.
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 treatment planpatients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow. | Procedure or surgery | extraction treatment |
Primary outcome
third molar angulation
Time frame: at the end of orthodontic treatment
The angulation of the mandibular third molars
4 secondary outcomes
space available for the upper and lower third molar
Time frame: at the end of orthodontic treatment
Angulation of the third molar.
Time frame: at the end of orthodontic treatment
The vertical position of the third molars
Time frame: at the end of orthodontic treatment
the mineralization status of the third molars
Time frame: at the end of orthodontic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No. the pre-treatment and post-treatment records
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.
amira aboalnaga principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extraction orthodontic treatment plan in people with Orthodontic Treatment Via Premolar Extraction, 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 3 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: status not confirmed, as of the sponsor's last update on 7 Sep 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?
Results are not available in the source record.
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?
third molar angulation (time frame: at the end of orthodontic treatment). 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 7 Sep 2023.