Mandibular Dental CrowdingNCT07169968
Effects of Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners
A study testing clear aligners group and micro-osteoperforations group in people with Mandibular Dental Crowding, run by Ain Shams University at 1 site in Egypt.
Trial summary
this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Dental Crowding
- What is being tested?
- clear aligners group and micro-osteoperforations group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients with age ranging from 18 to 35 years.
- Healthy periodontium.
- Presence of full set of permanent dentition excluding third molars.
- Patients requiring non-extraction orthodontic treatment in the mandibular arch.
- Mandibular anterior little's irregularity index from 3 to 6.
- No spaces in the mandibular arch.
Who cannot join
- Presence of retained primary teeth in the mandibular arch.
- Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs)
- Vulnerable patients.
- Smokers.
- Pregnant female patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of orthodontics, Faculty of Dentistry, Ain Shams University
Cairo, Abassia, 11566
About this study
Official title: Evaluation of the Effects of Micro-Osteoperforations on The Efficiency of Orthodontic Clear Aligner Therapy for Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations
Read the detailed description
This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations
- Conditions
- Mandibular Dental Crowding
- Being tested
- clear aligners group, micro-osteoperforations group
- Keywords
- Micro-osteoperforations, aligner tracking, lower anterior crowding, clear aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear aligners groupDevice
Also called control group, group 1
patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished
micro-osteoperforations groupDevice
Also called experimental group, group 2
patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment.
| Study group | Role | What they receive |
|---|---|---|
| group 1: Clear aligner treatment | Active comparator | the control group that will receive clear aligner treatment for lower anterior treatment without micro-osteoperforations Receives: Device: clear aligners group |
| group 2: clear aligner treatment with micro-osteoperforations | Experimental | the experimental group that will receive clear aligner treatment for lower anterior treatment with micro-osteoperforations using mini-implants for acceleration of tooth movement and improving aligner's tracking Receives: Device: micro-osteoperforations group |
What is being measured
The primary outcome is the main question the study is designed to answer.
aligner effectivness
Number of aligners prescribed versus required (total number of aligners including refinements) for each group
Measured: 3-9 months
Secondary outcomes (5)
relief of dental crowding
relief of crowding will be assessed using Little's Irregularity Index
Measured: 3-9 months
gingival assessment
measuring gingival index before and after treatment
Measured: 3-9 months
pain assessment
evaluating pain experienced after micro-osteoperforation using Visula Analoge score (VAS)
Measured: from day 1 to day 7 after micro-osteoperforations
periodontal assessment
measuring periodontal pocket depth before and after teatment
Measured: 3-9 months
tooth mobility assessment
measuring mobility index before and after treatment
Measured: 3-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Aug 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Dental CrowdingStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169968
- Sponsor's protocol ID
- FDASU-Rec ID052429
- Status last verified
- Jun 2025
- First submitted
- 21 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Micro-Osteoperforations on The Efficiency of Orthodontic Clear Aligner Therapy for Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07169968
- Acronym / sponsor ID
- FDASU-Rec ID052429
- Conditions
- Mandibular Dental Crowding
- Keywords
- Micro-osteoperforations, aligner tracking, lower anterior crowding, clear aligners
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 12 Sep 2025 (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.
this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations
Detailed description
This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: Clear aligner treatment | Active comparator | Device: clear aligners groupthe control group that will receive clear aligner treatment for lower anterior treatment without micro-osteoperforations |
| group 2: clear aligner treatment with micro-osteoperforations | Experimental | Device: micro-osteoperforations groupthe experimental group that will receive clear aligner treatment for lower anterior treatment with micro-osteoperforations using mini-implants for acceleration of tooth movement and improving aligner's tracking |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients with age ranging from 18 to 35 years.
- Healthy periodontium.
- Presence of full set of permanent dentition excluding third molars.
- Patients requiring non-extraction orthodontic treatment in the mandibular arch.
- Mandibular anterior little's irregularity index from 3 to 6.
Key exclusion criteria (5 listed)
- Presence of retained primary teeth in the mandibular arch.
- Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs)
- Vulnerable patients.
- Smokers.
- Pregnant female patients.
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 |
|---|---|---|
| clear aligners groupAlso: control group, group 1patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished | Device | group 1: Clear aligner treatment |
| micro-osteoperforations groupAlso: experimental group, group 2patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment. | Device | group 2: clear aligner treatment with micro-osteoperforations |
Primary outcome
aligner effectivness
Time frame: 3-9 months
Number of aligners prescribed versus required (total number of aligners including refinements) for each group
5 secondary outcomes
relief of dental crowding
Time frame: 3-9 months
gingival assessment
Time frame: 3-9 months
pain assessment
Time frame: from day 1 to day 7 after micro-osteoperforations
periodontal assessment
Time frame: 3-9 months
tooth mobility assessment
Time frame: 3-9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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?
A study testing clear aligners group and micro-osteoperforations group in people with Mandibular Dental Crowding, run by Ain Shams 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
aligner effectivness (time frame: 3-9 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 Sep 2025; AzTrials last refreshed its copy on 3 Nov 2026.