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

NCT05492773 | Recruiting

• 1 other identifier: Hama University -Ortho
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 2.a group of patients in which participants will be received treatment with the traditional clear aligners technique alone

Conditions

Crowding of Anterior Mandibular Teeth

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• Overall treatment Time

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

  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)

• Change in the levels of pain

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

• Satisfaction using VAS

  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

• Satisfaction with the ease of the procedure

  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,

• Satisfaction through acceptability of the procedure

  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,]

• Satisfaction through recommending the procedure

  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

Study Arms (2)

Micro-osteoperforations

EXPERIMENTAL

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.

Device: Micro-osteoperforations Technique

Clear aligner

EXPERIMENTAL

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

Device: Active comparater

Interventions

Micro-osteoperforations Technique 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.

Micro-osteoperforations

Active comparater DEVICE

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

Clear aligner

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hama University: lead

Study Sites (1)

Hama University

Hama, Syria

RECRUITING

Related Publications (8)

• 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.

  PMID: 24182579 BACKGROUND

• 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.

  PMID: 32610360 BACKGROUND

• 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.

  PMID: 34407180 BACKGROUND

• 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.

  PMID: 19361724 BACKGROUND

• 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.

  PMID: 24367643 BACKGROUND

• 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.

  PMID: 27667817 BACKGROUND

• 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.

  PMID: 29160349 BACKGROUND

• 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.

  PMID: 34093218 BACKGROUND

Study Officials

• Zouha Barram

  Hama University

  PRINCIPAL INVESTIGATOR

• Rabab AlSabbag, Professor

  Hama University

  STUDY DIRECTOR

Central Study Contacts

Zouha Barram, MSc Student

CONTACT

00963964617577; barramzouha@gmail.com

Fadi Jnaid, DDS,MSc,PhD

CONTACT

00963988499015; Drfadijnaid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 9, 2022
• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)