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

NCT ID: NCT03888560

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2021-04-14

Brief Summary

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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.

Detailed Description

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Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries \& enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a flap.Control group will not received any MOP and will receive standard orthodontic treatment.

Conditions

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Malocclusion

Keywords

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micro-osteperforation orthodontic tooth movement treatment duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Micro-osteoperforations

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.

Group Type EXPERIMENTAL

Micro-osteoperforations

Intervention Type 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

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Micro-osteoperforations

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nik Nuraini Nik Azmin

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

lorretha p ringgingon

Role: PRINCIPAL_INVESTIGATOR

faculty of dentistry university of malaya

Saritha Sivarajan

Role: STUDY_DIRECTOR

faculty of dentistry university of malaya

wey mang chek

Role: STUDY_DIRECTOR

faculty of dentistry university of malaya

mona fayed

Role: STUDY_DIRECTOR

faculty of dentistry university of malaya

Locations

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Faculty of Dentistry , University of Malaya

Kajang, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 20639508 (View on PubMed)

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)

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.

Reference Type BACKGROUND
PMID: 29853235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30372126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30281397 (View on PubMed)

Other Identifiers

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DGD170005

Identifier Type: -

Identifier Source: org_study_id