NCT02571348

Brief Summary

This study is intended to investigate the optimum interval between micro-osteoperforations to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated site. Next, the investigator will be comparing the rate of orthodontic tooth movement for micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the investigator will be evaluating the pain intensity and impact of pain on quality of life during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the investigator will be comparing the rate of orthodontic tooth movement between maxilla and mandible. The significance of the outcome is to determine optimum recommended interval for micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding out the optimum interval, the investigator can come with a recommended interval of micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth movement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

October 5, 2015

Last Update Submit

December 28, 2016

Conditions

Accelerated Tooth Movement Interval

Outcome Measures

Primary Outcomes (1)

  • rate of orthodontic tooth movement between micro osteoperforated site and non micro-osteoperforated site.

    through study completion, an average of 2 years

Secondary Outcomes (3)

  • Rate of orthodontic tooth movement between maxilla and mandible.

    through study completion, an average of 2 years

  • Rate of orthodontic tooth movement when micro-osteperforation performed at 4, 8 and 12 weeks intervals.

    through study completion, an average of 2 years

  • Pain intensity and impact of pain on patient's daily functions during different intervals of micro-osteoperforations at 4, 8 and 12 weeks using questionnaire.

    through study completion, an average of 2 years

Study Arms (3)

4 weeks and 8 weeks

ACTIVE COMPARATOR

Micro-osteoperforation will be done on either side of the maxilla at 4 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 8 weeks and the contralateral site will serve as the control

Procedure: micro-osteoperforation

8 weeks and 12 weeks

ACTIVE COMPARATOR

Micro-osteoperforation will be done on either side of the maxilla at 8 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 12 weeks and the contralateral site will serve as the control

Procedure: micro-osteoperforation

12 weeks and 4 weeks

ACTIVE COMPARATOR

Micro-osteoperforation will be done on either side of the maxilla at 12 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 4 weeks and the contralateral site will serve as the control

Procedure: micro-osteoperforation

Interventions

micro-osteoperforationPROCEDURE

micro-osteoperforation with mini implant at different interval

12 weeks and 4 weeks4 weeks and 8 weeks8 weeks and 12 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Molar Class I malocclusion, molar Class II \& III \< ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with temporary anchorage device (TAD)
  • Average vertical facial proportions
  • No systemic disease
  • Good oral hygiene
  • No history of periodontal therapy
  • No current active periodontal disease

You may not qualify if:

  • 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
  • Past periodontal disease
  • Current periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (6)

  • Alikhani M, Khoo E, Alyami B, Raptis M, Salgueiro JM, Oliveira SM, Boskey A, Teixeira CC. Osteogenic effect of high-frequency acceleration on alveolar bone. J Dent Res. 2012 Apr;91(4):413-9. doi: 10.1177/0022034512438590. Epub 2012 Feb 14.

    PMID: 22337699RESULT

  • 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: 20639508RESULT

  • Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.

    PMID: 19641146RESULT

  • Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level reactions to orthodontic force. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):469.e1-32. doi: 10.1016/j.ajodo.2005.10.007.

    PMID: 16627171RESULT

  • Ren Y, Kuijpers-Jagtman AM, Maltha JC. Immunohistochemical evaluation of osteoclast recruitment during experimental tooth movement in young and adult rats. Arch Oral Biol. 2005 Dec;50(12):1032-9. doi: 10.1016/j.archoralbio.2005.04.005. Epub 2005 Jun 15.

    PMID: 15963453RESULT

  • Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21.

    PMID: 22720793RESULT

Study Officials

  • Wey Mang Check

    Faculty of Dentistry, University of Malaya

    PRINCIPAL INVESTIGATOR

  • Jennifer Geraldine Doss

    Faculty of Dentistry, University of Malaya

    PRINCIPAL INVESTIGATOR

  • Saritha Sivarajan

    Faculty of Dentistry, University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 8, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

MY(1)