Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:

NCT03888560 | Completed DMC

• 1 other identifier: DGD170005
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment between micro-osteoperforations group and control group.

Conditions

Malocclusion

Keywords

micro-osteperforation; orthodontic tooth movement; treatment duration

Outcome Measures

Primary Outcomes (4)

• 1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).

  Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine

  5 months

• 2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.

  Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine

  5 months

• 3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.

  Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine

  5 months

• 4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.

  Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine

  5 months

Secondary Outcomes (3)

• Total volume of root resorption with micro-osteoperforations group vs the control group

  5 months

• Gingival recession between micro-osteoperforations and control group.

  5 months

• Black triangle between micro-osteoperforations and control group.

  5 months

Study Arms (2)

Micro-osteoperforations

EXPERIMENTAL

Lower arch, 2 MOPs vertically at interdental area bilaterally mesial to lower 6's ; mesial to lower 1st premolar; mesial to lower 2's and between the lower 1's..The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the experimental group until the completion of lower labial segment alignment (LLS), which is when the Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine.

Device: Micro-osteoperforations

control

NO INTERVENTION

Conventional orthodontic treatment without any aid in tooth acceleration method / device

Interventions

Micro-osteoperforations DEVICE

MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites

Micro-osteoperforations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender : Male and Female
• Age range : ≥ 18years to 45 years old
• Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
• Class II div I Incisor relationship with extraction of both upper 1st premolars
• Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
• Average vertical facial proportions
• No systemic disease
• Acceptable good oral hygiene
• No periodontal disease

You may not qualify if:

• Smokers
• Distally angulated canines
• History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
• Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
• Habits eg: fingernails biting , toothpick user , using hard toothbrush
• Vertical skeletal discrepancies eg high angle and low angle
• Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
• Poor oral hygiene for more than 3 visits
• Current periodontal disease

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry , University of Malaya

Kajang, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (5)

• Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.

  PMID: 20639508 BACKGROUND

• 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

• Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.

  PMID: 29853235 BACKGROUND

• Sivarajan S, Doss JG, Papageorgiou SN, Cobourne MT, Wey MC. Mini-implant supported canine retraction with micro-osteoperforation: A split-mouth randomized clinical trial. Angle Orthod. 2019 Mar;89(2):183-189. doi: 10.2319/011518-47.1. Epub 2018 Oct 29.

  PMID: 30372126 BACKGROUND

• Attri S, Mittal R, Batra P, Sonar S, Sharma K, Raghavan S, Rai KS. Comparison of rate of tooth movement and pain perception during accelerated tooth movement associated with conventional fixed appliances with micro-osteoperforations - a randomised controlled trial. J Orthod. 2018 Dec;45(4):225-233. doi: 10.1080/14653125.2018.1528746. Epub 2018 Oct 3.

  PMID: 30281397 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nik Nuraini Nik Azmin

  University of Malaya

  PRINCIPAL INVESTIGATOR

• lorretha p ringgingon

  faculty of dentistry university of malaya

  PRINCIPAL INVESTIGATOR

• Saritha Sivarajan

  faculty of dentistry university of malaya

  STUDY DIRECTOR

• wey mang chek

  faculty of dentistry university of malaya

  STUDY DIRECTOR

• mona fayed

  faculty of dentistry university of malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of either patient or clinician is not possible during allocation, treatment and data collection. However, blinding can be ensured during data processing, analysing stages and data collection for secondary outcomes on total volume of root resorption from CBCT, formation of black triangle and gingiva recession
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the MOP group until the completion of lower labial segment alignment (LLS), which is when the LII scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. At the end of alignment stage, the date for completion of alignment was recorded (T2), from which the overall alignment time (OAT) in days, required to complete LLS alignment, were calculated. Measurements were done clinically using an electric digital caliper. At this point, perforations were stopped. Gingival recession and black triangle were then recorded and measured. Patients were referred for CBCT images to evaluate for root resorption.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 25, 2019
• Study Start: November 19, 2018
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)