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Crowding of Anterior Mandibular TeethNCT05492773

Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners

A study testing Micro-osteoperforations Technique and Active comparater in people with Crowding of Anterior Mandibular Teeth, run by Hama University at 1 site in Syria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients with moderate mandibular anterior crowding will be treated in this study. The efficacy of micro-osteoperforations technique by special drill in accelerating orthodontic tooth movement during clear aligners therapy will be assessed along with patient's pain and satisfaction. There are two groups: 1. Read more about this study

Who is it for?
Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Crowding of Anterior Mandibular Teeth
What is being tested?
Micro-osteoperforations Technique and Active comparater
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSyria
Study dates
10 Dec 2026to 4 Dec 2027
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 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Completion of permanent dentition (except third molars)
  • Moderate crowding (4-6 mm according to Little's index)
  • Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
  • Number of aligners ≥ 8 aligners.

Who cannot join

  • • Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
  • Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
  • Patients had previous orthodontic treatments
  • Poor oral hygiene or concurrent periodontal disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zouha Barram, MSc Student contact

00963964617577

barramzouha@gmail.com

Fadi Jnaid, DDS,MSc,PhD contact

00963988499015

Drfadijnaid@gmail.com

Syria1 site, 1 recruiting
  • Hama University

    Hama

    Fadi Jnaid, 988499015, Drfadijnaid@gmail.com

    Recruiting

Other trials in Syria

About this study

Official title: Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration of Dental Crowding Cases Treated With Clear Aligners: A Randomized Controlled Clinical Trial

Patients with moderate mandibular anterior crowding will be treated in this study. The efficacy of micro-osteoperforations technique by special drill in accelerating orthodontic tooth movement during clear aligners therapy will be assessed along with patient's pain and satisfaction.

There are two groups:

  1. a group of patients in which participants will be received treatment with the traditional clear aligners technique in addition to a micro-osteoperforations technique.
  2. a group of patients in which participants will be received treatment with the traditional clear aligners technique alone
Read the detailed description

Dental crowding is one of the most common orthodontic problems in adults as it was found that 80% of adults had crowding in the lower incisors area.

Although many adults need orthodontic treatment, they do not like and sometimes refuse to apply fixed orthodontic devices, so the emergence of Clear Aligners Technique (CAT) where the aesthetic aspect is one of the most important characteristics of this technique which can alleviate the response and anxiety of adult patients related to orthodontic treatment, its approach relies on the use of a series of clear aligners that slowly move each tooth into the desired position.

But the strict protocol that requires wearing each aligner 22 hours a day leads to poor patient compliance with it during the treatment period, so many clinical and laboratory attempts have been made to find different methods that achieve faster results and reduce the extent of orthodontic treatment, and among all the previous methods, the surgical approach is the most clinically used and the most tested with known expectations and stable results.

Although these surgical methods have proven effective, they are considered aggressive in nature as they require lifting of full-thickness buccal and lingual flaps with extensive removal of the buccal and lingual cortical bone, in addition to the fact that they may face rejection of the patient due to anxiety and fear of pain and undergo surgery, patients are usually not open toward ideas involving surgery unless it is the only option to obtain a good bite.

Hence, the interest has increased dramatically in recent years to develop conservative surgical techniques that provide similar clinical efficacy with minimal trauma and greater acceptance by patients. One of these techniques is the micro-osteoperforations technique, which is ideal for adult patients who have limited time and wish to finish their treatment as quickly as possible.

To date, no randomized controlled trial (RCT) has been conducted to study the effects of micro-osteoperforations Technique on the duration of orthodontic treatment along with patient's pain and satisfaction during clear aligner therapy (CAT) in moderate mandibular anterior crowding cases which are one of the most common types of malocclusions.

The current study will have two parallel arms as following:

Group 1 (the intervention group): patients in which participants will be received treatment with the traditional clear aligners technique in addition to a micro-osteoperforations technique.

Group 2 (the control group): patients in which participants will be received treatment with the traditional clear aligners technique alone.

In the intervention and control groups: patients will change aligners depending on the fit of the new aligner.

In the intervention group:

On the placing day of the initial clear aligner, special drill (1 mm in diameter and 10 mm in length) were used to perform the MOPs procedure in the intervention group. Buccal transmucosal MOPs were performed between mandibular canine and first mandibular premolar bilaterally and between mandibular canine and lateral incisor bilaterally and between mandibular lateral incisor and central incisor bilaterally and between central incisors in the midline on labial aspect of mandible.

Two MOPs at each site were performed, first perforation will be performed at a distance of 2mm from free gingival margin and second perforation will be performed 2mm from the first one in a vertical line (which will measure using customized length guides on special drill), making a total of fourteen MOPs.

The depth of perforation will be 1mm in buccal cortical bone (which will measure using customized depth guides on special drill).

Being tested
Micro-osteoperforations Technique, Active comparater

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micro-osteoperforations TechniqueDevice

    Micro-Osteoperforations Technique (MOPs) Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement.

  • Active comparaterDevice

    Active Comparator: Traditional treatment The patients in this group will be receive treatment with the traditional clear aligners technique without any surgical procedure.

Study groups in NCT05492773
Study groupRoleWhat they receive
Micro-osteoperforationsExperimentalExperimental: Micro-Osteoperforations Technique(MOPs) Experimental: Micro-Osteoperforations Technique(MOPs) Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement.
Receives: Device: Micro-osteoperforations Technique
Clear alignerExperimentalTraditional treatment The patients in this group will be receive treatment with the traditional clear aligners technique without any surgical procedure.
Receives: Device: Active comparater

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Little's Index of Irregularity

    The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

    Measured: T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after 5 months when Little's Index of Irregularity less than 1 mm and final aligner does not apply any pressure

  2. Overall treatment Time

    the overall time required to complete the treatment was calculated by calculating the number of days between (To) and (T3).

    Measured: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,

Secondary outcomes (5)
  1. Change in the levels of pain

    Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.

    Measured: 4 ,12,24,48 hours following the onset of orthodontic treatment

  2. Satisfaction using VAS

    satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.

    Measured: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it

  3. Satisfaction with the ease of the procedure

    is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.

    Measured: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,

  4. Satisfaction through acceptability of the procedure

    Patients in micro-Osteoperforations group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No).

    Measured: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,]

  5. Satisfaction through recommending the procedure

    Recommendation to a friend: Patients in micro-Osteoperforations group were asked about making recommendation to a friend, and they answered using a two-point scale (1. Yes or 2. No).

    Measured: After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start10 Dec 2026 (estimated)
  3. Primary completion4 May 2027 (estimated)
  4. Study completion4 Dec 2027 (estimated)

Resources

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
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492773
Sponsor's protocol ID
Hama University -Ortho
Status last verified
Sep 2025
First submitted
29 Jul 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.

    PubMed 24182579
  • Al-Khalifa KS, Baeshen HA. Micro-osteoperforations and Its Effect on the Rate of Tooth Movement: A Systematic Review. Eur J Dent. 2021 Feb;15(1):158-167. doi: 10.1055/s-0040-1713955. Epub 2020 Jul 1.

    PubMed 32610360
  • Al-Dboush R, Esfahani AN, El-Bialy T. Impact of photobiomodulation and low-intensity pulsed ultrasound adjunctive interventions on orthodontic treatment duration during clear aligner therapy. Angle Orthod. 2021 Sep 1;91(5):619-625. doi: 10.2319/112420-956.1.

    PubMed 34407180
  • Monnerat C, Restle L, Mucha JN. Tomographic mapping of mandibular interradicular spaces for placement of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):428.e1-9; discussion 428-9. doi: 10.1016/j.ajodo.2008.12.003.

    PubMed 19361724
  • Purmal K, Alam MK, Pohchi A, Abdul Razak NH. 3D mapping of safe and danger zones in the maxilla and mandible for the placement of intermaxillary fixation screws. PLoS One. 2013 Dec 19;8(12):e84202. doi: 10.1371/journal.pone.0084202. eCollection 2013.

    PubMed 24367643
  • Sadek MM, Sabet NE, Hassan IT. Three-dimensional mapping of cortical bone thickness in subjects with different vertical facial dimensions. Prog Orthod. 2016 Dec;17(1):32. doi: 10.1186/s40510-016-0145-x. Epub 2016 Oct 17.

    PubMed 27667817
  • Tepedino M, Cattaneo PM, Masedu F, Chimenti C. Average interradicular sites for miniscrew insertion: should dental crowding be considered? Dental Press J Orthod. 2017 Sep-Oct;22(5):90-97. doi: 10.1590/2177-6709.22.5.090-097.oar.

    PubMed 29160349
  • Wang Y, Shi Q, Wang F. Optimal Implantation Site of Orthodontic Micro-Screws in the Mandibular Anterior Region Based on CBCT. Front Physiol. 2021 May 20;12:630859. doi: 10.3389/fphys.2021.630859. eCollection 2021.

    PubMed 34093218

Questions about this trial

What is this clinical trial studying?

A study testing Micro-osteoperforations Technique and Active comparater in people with Crowding of Anterior Mandibular Teeth, run by Hama University at 1 site in Syria.

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 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 Syria. 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?

Contact Zouha Barram, MSc Student (00963964617577, barramzouha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Little's Index of Irregularity (time frame: T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after 5 months when Little's Index of Irregularity less than 1 mm and final aligner does not apply any pressure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05492773, which also lists 8 linked publications.

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 16 Sep 2026.

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