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

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Micro-osteoperforations
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring micro-osteperforation, orthodontic tooth movement, treatment duration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry , University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Micro-osteoperforations

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Total volume of root resorption with micro-osteoperforations group vs the control group
Total volume of root resorption in cubic millimeter (mm3) using 3D Cone Beam CT imaging scanner compare at baseline and end of LLS alignment
Gingival recession between micro-osteoperforations and control group.
Gingival recession assessed in millimetre (mm) from cement-enamel junction (CEJ) to free gingival margin using electric digital calliper with an accuracy of 0.01mm, at baseline and end LLS alignment
Black triangle between micro-osteoperforations and control group.
Presence of black triangle for interdental at baseline and end of LLS alignment

Full Information

First Posted
March 13, 2019
Last Updated
October 26, 2021
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03888560
Brief Title
Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:
Acronym
MOP
Official Title
Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
micro-osteperforation, orthodontic tooth movement, treatment duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micro-osteoperforations
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
Conventional orthodontic treatment without any aid in tooth acceleration method / device
Intervention Type
Device
Intervention Name(s)
Micro-osteoperforations
Intervention Description
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
Primary Outcome Measure Information:
Title
1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
Description
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
Time Frame
5 months
Title
2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
Description
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
Time Frame
5 months
Title
3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
Description
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
Time Frame
5 months
Title
4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
Description
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
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Total volume of root resorption with micro-osteoperforations group vs the control group
Description
Total volume of root resorption in cubic millimeter (mm3) using 3D Cone Beam CT imaging scanner compare at baseline and end of LLS alignment
Time Frame
5 months
Title
Gingival recession between micro-osteoperforations and control group.
Description
Gingival recession assessed in millimetre (mm) from cement-enamel junction (CEJ) to free gingival margin using electric digital calliper with an accuracy of 0.01mm, at baseline and end LLS alignment
Time Frame
5 months
Title
Black triangle between micro-osteoperforations and control group.
Description
Presence of black triangle for interdental at baseline and end of LLS alignment
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nik Nuraini Nik Azmin
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
lorretha p ringgingon
Organizational Affiliation
faculty of dentistry university of malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saritha Sivarajan
Organizational Affiliation
faculty of dentistry university of malaya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
wey mang chek
Organizational Affiliation
faculty of dentistry university of malaya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mona fayed
Organizational Affiliation
faculty of dentistry university of malaya
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry , University of Malaya
City
Kajang
State/Province
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20639508
Citation
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.
Results Reference
background
PubMed Identifier
24182579
Citation
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.
Results Reference
background
PubMed Identifier
29853235
Citation
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.
Results Reference
background
PubMed Identifier
30372126
Citation
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.
Results Reference
background
PubMed Identifier
30281397
Citation
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.
Results Reference
background

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

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