Crowding of Anterior Maxillary TeethNCT05605652
Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With MOPs :A Comparative Clinical Study
A study testing microosteoperforations in people with Crowding of Anterior Maxillary Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Maxillary Teeth
- What is being tested?
- microosteoperforations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jul 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Class 1 skeletal pattern with normal facial proportions. 2. Patients with age range between 13 -19 years. 3. Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.
- 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.
Who cannot join
- 1. Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area. 3. Poor oral hygiene 4. Present or history of periodontal diseases. 5. Physical or mental disability. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With Micro-osteoperforations:A Comparative Clinical Study.
The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth.
Read the detailed description
The current study will be conducted on a group of orthodontic patients attending the out patients clinic, Orthodontic Department, Faculty of Dental Medicine (Boys), AL- Azhar University, Cairo
The patient will be randomly assigned into two equal groups:
- Experimental group: Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire.
- Control group: leveling and alignment will be commenced without micro- osteoperforations.
- Conditions
- Crowding of Anterior Maxillary Teeth
- Being tested
- microosteoperforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microosteoperforationsProcedure or surgery
Also called MOPs
Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline
alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | leveling and alignment will be commenced without micro- osteoperforations |
| Experimental group | Experimental | Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline
alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire. Receives: Procedure: microosteoperforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).
- Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).
Measured: 2months-6months
• Overall time needed to complete leveling and alignment of maxillary anterior segment
- Overall time needed to complete leveling and alignment of maxillary anterior segment was calculated by the number of days between day of inserting the 1st archwire and at the end of the leveling and alignment stage.
Measured: 2months -6months
• Alignment improvement percentage
- Alignment improvement percentage was calculated by dividing the amount of change in the LII value at a specific time point (calculated by subtracting the LII value at T1, T2, or T3 from the LII value at T0) by LII value at T0.
Measured: 2months -6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Jun 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding of Anterior Maxillary TeethStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed abd elsalam abo donia, Al-Azhar University
- Investigators
- Raafat GH Mohamad, Asst Prof, Study chair, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar UniversityAhmed A El-Awady, Lecturer, Study director, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605652
- Sponsor's protocol ID
- 660/301
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With Micro-osteoperforations:A Comparative Clinical Study.
- ClinicalTrials.gov ID
- NCT05605652
- Acronym / sponsor ID
- 660/301
- Conditions
- Crowding of Anterior Maxillary Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 4 Nov 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.
The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth.
Detailed description
The current study will be conducted on a group of orthodontic patients attending the out patients clinic, Orthodontic Department, Faculty of Dental Medicine (Boys), AL- Azhar University, Cairo
The patient will be randomly assigned into two equal groups:
- Experimental group: Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire.
- Control group: leveling and alignment will be commenced without micro- osteoperforations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –leveling and alignment will be commenced without micro- osteoperforations |
| Experimental group | Experimental | Procedure: microosteoperforationsFlapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1. Class 1 skeletal pattern with normal facial proportions. 2. Patients with age range between 13 -19 years. 3. Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.
- 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.
Key exclusion criteria (1 listed)
- 1. Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area. 3. Poor oral hygiene 4. Present or history of periodontal diseases. 5. Physical or mental disability. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
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 |
|---|---|---|
| microosteoperforationsAlso: MOPsFlapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire. | Procedure or surgery | Experimental group |
Primary outcome
• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).
Time frame: 2months-6months
• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).
• Overall time needed to complete leveling and alignment of maxillary anterior segment
Time frame: 2months -6months
• Overall time needed to complete leveling and alignment of maxillary anterior segment was calculated by the number of days between day of inserting the 1st archwire and at the end of the leveling and alignment stage.
• Alignment improvement percentage
Time frame: 2months -6months
• Alignment improvement percentage was calculated by dividing the amount of change in the LII value at a specific time point (calculated by subtracting the LII value at T1, T2, or T3 from the LII value at T0) by LII value at T0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Related trials for Crowding of Anterior Maxillary Teeth
Recruiting
Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition
Crowding of Anterior Maxillary Teeth, Orthodontics, Interceptive
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.
Raafat GH Mohamad, Asst Prof study chair
Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
Ahmed A El-Awady, Lecturer study director
Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar 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 microosteoperforations in people with Crowding of Anterior Maxillary Teeth, run by Al-Azhar 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 2 inclusion and 1 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 4 Nov 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?
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?
• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII). (time frame: 2months-6months). The study lists 3 primary outcomes in all. 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 4 Nov 2022.