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

NCT ID: NCT05492773

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-10
• Study Completion Date: 2026-12-04

Brief 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. 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

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).

Conditions

Crowding of Anterior Mandibular Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Micro-osteoperforations

Experimental: 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.

Group Type: EXPERIMENTAL

Micro-osteoperforations Technique

Intervention Type: DEVICE

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

Clear aligner

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

Group Type: EXPERIMENTAL

Active comparater

Intervention Type: DEVICE

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

Interventions

Micro-osteoperforations Technique

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

Intervention Type: DEVICE

Active comparater

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hama University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zouha Barram

Role: PRINCIPAL_INVESTIGATOR

Hama University

Rabab AlSabbag, Professor

Role: STUDY_DIRECTOR

Hama University

Locations

Hama University

Hama, , Syria

Site Status: RECRUITING

Countries

Syria

Central Contacts

Zouha Barram, MSc Student

Role: CONTACT

barramzouha@gmail.com

00963964617577

Fadi Jnaid, DDS,MSc,PhD

Role: CONTACT

Drfadijnaid@gmail.com

00963988499015

Facility Contacts

Fadi Jnaid

Role: primary

Drfadijnaid@gmail.com

988499015

References

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.

Reference Type: BACKGROUND

PMID: 24182579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32610360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34407180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19361724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24367643 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27667817 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29160349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34093218 (View on PubMed)

Other Identifiers

Hama University -Ortho

Identifier Type: -

Identifier Source: org_study_id